Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE Guidance 41 Author: J.L. Cartwright, SpR Public Health Date: 19/06/08 Version: 2 Status: Final Version Intended Audience: Cancer Services Coordinating Group - breast Applicability: Screening Services Meeting Date: CSCG, 20/06/08 Review Date: N/A Relevant Previous Documents: N/A Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 1 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Purpose of Document: To provide advice to Welsh Assembly Government regarding the implementation of NICE clinical guidance 41 for Wales. Publication/Distribution: Publication in NPHS Document Database (Specify Database) Link from NPHS e-Bulletin Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 2 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Table of Contents Executive Summary...................................................................................................5 1 Introduction.........................................................................................................8 2 Aim .......................................................................................................................8 3 Objectives ...........................................................................................................8 4 Methods ...............................................................................................................9 5 Background....................................................................................................... 10 5.1 Familial Breast cancer .............................................................................. 10 5.2 Clinical genetics service ........................................................................... 11 5.2.1 Referral criteria ........................................................................................ 11 5.2.2 Calculation of breast cancer risk .............................................................. 14 5.3 NICE clinical guidance .............................................................................. 16 5.3.1 Summary of NICE Clinical Guidance 41 recommendations on MRI breast surveillance......................................................................................................... 17 6 Results .............................................................................................................. 20 6.1 Current surveillance system .................................................................... 20 Epidemiology of women currently offered surveillance. .................................. 22 6.1.1 Age range ................................................................................................ 22 6.1.2 Area of residence ..................................................................................... 23 6.1.3 Trends over time ...................................................................................... 24 6.2 Expected number of women registered in the Family History Programme following NICE guidance implementation ..................................... 26 6.3 Current MRI scanners in Wales ................................................................ 28 6.3.1 Ability of current MRI Scanners to meet identified need .......................... 28 6.4 7 8 Comparative surveillance systems .......................................................... 31 Options for provision ....................................................................................... 32 7.1 MRI in Breast Test Wales .......................................................................... 32 7.2 Acute Trusts .............................................................................................. 33 7.3 Breast Test Wales/ Acute trust hybrid ..................................................... 33 Appraisal ........................................................................................................... 34 8.1 Call/recall ................................................................................................... 34 8.2 Radiology expertise .................................................................................. 35 8.3 Staffing ....................................................................................................... 36 8.4 MR capacity ............................................................................................... 36 8.5 Standards and quality assurance ............................................................ 37 Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 3 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust 8.6 9 Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Access ........................................................................................................ 38 Recommendations ........................................................................................... 38 10 Reference List ................................................................................................... 40 Appendix 1.UK MRI Breast screening protocol .................................................... 42 Appendix 2.Stakeholders consulted ...................................................................... 47 © 2008 National Public Health Service for Wales Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to the National Public Health Service for Wales to be stated. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 4 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Executive Summary Breast cancer is the most common cancer in women and accounts for between 1825% of all female malignancies world-wide. The lifetime risk (to 85 years of age) of developing breast cancer in more developed countries world-wide has been estimated in the UK at 11% (1 in 9 women). It has been estimated that up to 27% of women may have an inherited predisposition to breast cancer. Breast screening by mammography is provided by Breast Test Wales (BTW) for women aged 50 and over. Women under 50 years with a family history of breast cancer who were assessed by the All Wales medical genetics services (AWMGS) as having a moderate or high risk of developing the disease are also offered annual mammography by BTW, although this is not formally commissioned or funded. The BTW Family History Programme began in 2001. Since then 2363 women have been registered in the programme, women are aged between 30 and 65 years, and distributed across the whole of Wales. The number of mammographic screens performed per year for women on the family history programme has risen across all divisions to 1431 in 2006. NICE Clinical guidance 41, Familial breast cancer. The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care, recommends when, dependant on a woman’s age and risk of breast cancer, women would benefit from magnetic resonance imaging, MRI, breast surveillance. This is in Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 5 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 addition to, or as an alternative to, mammography as per previous recommendations. All women currently registered with the family history programme meet the NICE guidance criteria for annual MRI breast surveillance. In total for Wales there would be a need for 1700 MRI scans per annum for women known to the Family History Programme at present, and between 2000 and 2200 MRI scans per annum if women not currently known to the programme were recruited. Identified need for breast MRI can not be met within the existing MRI resource. The recent review of diagnostic imaging concluded that there is not the capacity in Wales to meet current targets without investment in workforce and equipment. The review specifically states that additional further investment would be necessary for provision of new services such as breast MRI surveillance. The recommendations of this report are: Investment in new MRI scanners and the specialist staff to operate a surveillance programme is imperative in order to implement NICE guidance 41. The model of provision should combine the experience and expertise of BTW in managing a call/recall system and operating quality assured screening services, with the capacity of the trusts to accommodate new MRI scanners and utilize their full capacity. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 6 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Three centres for breast surveillance are needed to ensure equality of access to the surveillance service. These would ideally be situated in specialist breast units in the North, South and West of Wales, allowing MRI capacity to be utilised in symptomatic breast services. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 7 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust 1 Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Introduction Breast screening by mammography is provided by Breast Test Wales (BTW) for women aged 50 and over. Women under 50 years with a family history of breast cancer which suggests they have an increased risk of developing the disease compared with the population as a whole are also offered annual mammography by BTW, although this is not funded. The age at which annual mammography is commenced is determined by the estimated level of risk for the individual from their family history. NICE clinical guidance 41 published in July 2006 recommended these women should receive annual MRI surveillance in addition to mammography. At present there is no system in Wales to provide this level of surveillance. This document explores the options for implementing the NICE guidance across Wales. 2 Aim To devise and appraise the options for the provision of MRI surveillance to women with a family history of breast cancer across Wales in line with NICE clinical guidance 41(1). 3 Objectives Describe current system of surveillance for women with a family history of breast cancer Determine the current number of women identified as eligible for breast surveillance and how many would be expected for a population equivalent to Wales Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 8 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Describe the location and specification of current MRI scanners, and compare with the UK standards for breast MR imaging(2). 4 Identify from the literature and service providers possible options for provision Appraise the strengths and weaknesses of identified options Methods Details of the current system of surveillance for women with a family history of breast cancer were obtained from Screening Services and The All-Wales Cancer Genetics Service. This information was triangulated with the descriptions of the current system from in depth interviews of other stakeholders, and published information. Anonymised data was obtained from Screening Services, Velindre NHS Trust, for women whose family history had been assessed, broken down by age; Local Health Board; and risk category. The number of quarterly referrals from the cancer genetics service, January 2001 to June 2007, by region was also obtained. The expected number of families and individuals with an increased risk of breast cancer due to a family history of breast cancer was obtained from peer reviewed published literature. The location and specification of current MRI scanners in Wales was obtained from the Welsh Health Estates division, and compared with the UK standards for MRI breast imaging published by the Royal College of Radiologists. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 9 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 A search of peer reviewed literature and scoping of the grey literature was undertaken along with in depth interviews with stakeholders to generate and appraise options for provision of the of MRI surveillance. 5 Background 5.1 Familial Breast cancer Breast cancer is the most common cancer in women and accounts for between 1825% of all female malignancies world-wide(3,4). Although breast cancer incidence and mortality varies considerably around the world, the proportion of women who develop breast cancer is higher in western, developed countries. The lifetime risk (to 85 years of age) of developing breast cancer in more developed countries world-wide has been estimated in the UK at 11% (1 in 9 women)(3-5). It has been estimated that up to 27% of women may have an inherited predisposition to breast cancer(6), although only 3-5% are likely to carry gene faults which conferred a very substantial (>50%) risk of breast cancer(7,8). Media reporting often gives the impression that a greater proportion of cases are linked to genetic inheritance. Since breast cancer is relatively common, it can be difficult for women to know whether any case in a relative indicates a familial inheritance or not. Questions about possible familial breast cancer may be expressed to (or raised by) general practitioners, symptomatic breast clinics, breast screening services and others. Most women do not develop breast cancer, and of those who do most will not have a known family history of the disease. Some women will have one relative who has had Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 10 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 a diagnosis of breast cancer. Often, these affected relatives will be in the older age range when a diagnosis of breast cancer is made. This type of family history does not result in increased risk of breast cancer in relatives and so women in this category are not discussed further in this report. Familial breast cancer typically occurs in women within a family where there have been an unusually high number of family members affected by breast cancer. If there have been more cases of breast or related cancers than would be expected by chance alone, it may be that genes transmitted between generations are sufficient to cause or, more typically, contribute to the development of breast cancer. The types of family histories pertinent to increased risk are discussed in the relevant sections along with referral criteria. 5.2 Clinical genetics service 5.2.1 Referral criteria The All Wales Medical Genetics services (AWMGS) was established in 1998. The AWMGS provides specialist genetic services to individuals and families with, or concerned about, rare genetic conditions. The service is made up of clinical and laboratory services which together provide medical genetics services to the population of Wales. Cardiff and Vale NHS Trust hosts the AWMGS at the University Hospital of Wales (UHW), Heath, Cardiff. Specialist consultant geneticists, doctors and genetic counselors provide genetic services in all the main hospitals throughout Wales. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 11 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 The Cancer Genetic Service in Wales (CGSW) is part of the All Medical Wales Genetics service. Its remit is to assess the risk of cancer based on the reported family history and work with the relevant specialists to recommend further screening strategies where appropriate. The service has referral criteria for clinicians in primary and secondary care which identify those who may be at significantly increased risk of an inherited form of cancer (Figure 1.). Figure 1. Criteria for referral to the cancer genetics service. Breast Cancer 1 first degree relative diagnosed at 40 years or less 2 first degree relatives at 60 years or less (on the same side of the family) 3 first or second degree relatives any age (on the same side of the family) 1 first degree male breast cancer A first degree relative with bilateral breast cancer N.B. breast cancer can also be inherited through the paternal side of the family Breast/Ovarian Cancer Minimum: 1 of each cancer in first degree relatives (If only one of each cancer, the breast cancer diagnosed under 50 years) A first degree relative who has both breast and ovarian cancer Source: The Cancer Genetics Service for Wales. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 12 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Once women are referred to the service, a detailed family history is taken by postal questionnaire. Confirmation of the type, site and age of onset of their relative’s cancer may be needed. Once accurate and complete information is obtained the family pedigree is drawn and an individuals risk of carrying a faulty gene and risk of developing cancer is calculated. Individual risk is expressed as: the same as background population risk; (less than 15% lifetime risk of breast cancer) moderate risk, (a greater than 15% lifetime risk of breast cancer) or high risk. (a greater than 15% lifetime risk of breast cancer and a heterozygote risk of 25% or more) Based upon this risk advice on the need for further surveillance or genetic testing can be given. Women assessed to be at low or population risk of breast cancer are reassured that, on the information given, their risk is not significantly raised above that of the general population, so extra surveillance is not suggested. It is clearly stated that individuals in this group still have the same risk (or perhaps slightly higher) of cancer as any other individual of the same age in the general population. They should continue the standard health awareness and screening as the general population. Women assessed as at moderate risk of breast cancer require ongoing management shared between primary care and appropriate specialist (for example the local Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 13 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 specialist breast surgeon). Women assessed to be at high risk of developing breast cancer are referred for specialist surveillance. This group is offered a genetics clinic appointment, and if appropriate, genetic testing. The genetics clinic offers time to discuss issues at length and genetic counseling regarding the risk of cancer. Where possible, confirmation of diagnoses and histology in the relative with cancer is obtained, and where appropriate arrangements are made for follow up of other family members at high risk; storage of DNA from affected individuals and organisation of molecular genetic testing. 5.2.2 Calculation of breast cancer risk Calculation of an individual woman’s risk of developing breast cancer is complex. There are breast cancer risks that all women are exposed to (population level); risks that sub-populations (e.g. certain types of family history) are exposed to and the risks for each individual woman. The risks of breast cancer can be expressed in terms of an age-specific risk (e.g. risk over the next five years), or a lifetime risk (e.g. risk to age 80). A large reanalysis of epidemiological data world-wide has found that the probability that women in more-developed countries will develop breast cancer increases st according to the number of affected 1 degree relatives(9)(1). The probability of a woman aged 20 who has no affected relatives developing breast cancer by the age of Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 14 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 80 is 7.8%, 1 affected relative, 13.3% and 2 affected relatives, 21.1%. The risk of developing breast cancer is greater the younger the relative is when she developed the disease. For example, a woman whose sister developed breast cancer between the ages of 30-39 has a cumulative risk of 10% of developing the disease herself by age 65, but that risk is only 5% (close to the population risk) if the sister was aged 5054 when breast cancer was diagnosed(4). It has been estimated that for a total population of 1 million with an age and sex structure comparable to that of England and Wales there would be 20-40 families whose family history of breast cancer would indicate that members had a high risk of developing breast cancer (1 in 4 lifetime risk)(10)(2). Furthermore, 4,450 women aged 35-49 would be estimated to be at moderate risk (1 in 6 lifetime risk) of developing the disease, out of a total of 47,000 women at risk. Family history, however, is not always a reliable indicator of those with gene mutations. Known gene mutations are implicated in only about 2-5% of all cases of breast cancer(5,11). It is not yet known how many breast cancer genes there may be, although two breast cancer genes, BRCA 1 and BRCA2, have been identified and account for a considerable proportion of very high risk families, that is, those with four or more close relatives who have breast cancer(4). Certain populations have been found to have different rates of certain genetic alterations. In the Ashkenazi Jewish community three “founder” mutations (two in BRCA1, one in BRCA2) are relatively common and explain almost all the high risk families due to these genes, and other populations have been found to have higher rates of BRCA1 and BRCA2 alterations (e.g. Norwegian, Dutch and Icelandic people). Breast cancer genes may be Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 15 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 transmitted through either sex and some family members may transmit the abnormal gene without developing cancer themselves. However, carrying the gene mutation gives a high lifetime risk of developing breast cancer; it is estimated that the risk is as high as 50% of developing the disease by the age of 50, rising to 85% (for some families) by the age of 70(10). Genetic, or hereditary, breast cancer is usually characterised by early onset, a high incidence of bilateral disease and an association with other malignancies; for instance, inherited factors are thought to contribute to 2535% of cases diagnosed before the age of 30(12). Indeed mutations in the known high risk genes BRCA1, BRCA2 and TP53 have been demonstrated in 20% of a population based sample of women with breast cancer aged 30 years and under(13). In most instances it is unlikely that a family history of breast cancer will be due to known high-risk genes such as BRCA1 or BRCA2 and we are only beginning to appreciate the contribution of other lower risk genes that may account for more breast cancer overall. In the absence of good epidemiological evidence on these other genes use of existing algorithms for calculating risk is still valid and most will take into account the possibility of such genes being involved. 5.3 NICE clinical guidance The Familial breast cancer guideline (NICE 14) was published in 2004(14). It did not recommend that MRI be used for routine surveillance. The guidance was reviewed in the light of emerging evidence, culminating in the publication of Clinical NICE Guidance 41 in October 2006(1). Guidance on other issues was not considered by this review and remained current. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 16 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Recent evidence has suggested that MRI screening increases the sensitivity of breast cancer screening at the expense of specificity(15). This additional sensitivity has the potential to identify cases sooner which ought to lead to more promising prognoses. Furthermore, a hastening of a correct identification can prevent disutility associated with false negatives prior to their eventual diagnosis. 5.3.1 Summary of NICE Clinical Guidance 41 recommendations on MRI breast surveillance These recommendations indicate when Magnetic Resonance Imaging (MRI) is to be used. This is in addition to, or as an alternative to, mammography as per the recommendations in the original guideline At entry to an MRI surveillance programme, and at each subsequent change in the programme, women should be provided with a documented plan which includes: • a clear description of the method(s) and intervals, including the risks and benefits • the reasons for any changes to the surveillance plan • sources of support and further information MRI of both breasts should be performed to high quality standards ensuring both high temporal and spatial resolution. Dynamic sequences are recommended post contrast. They should be double-read where possible. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 17 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 When mammography is recommended in women under 50, digital mammography should be used in preference to conventional mammography at centres where this is available to NHS Breast Screening Programme standards. Women who are known to have a genetic mutation should be offered annual MRI surveillance if they are: • BRCA1 and BRCA2 mutation carriers aged 30–49 years • TP53 mutation carriers aged 20 years or older Women who have been referred to a clinical genetics centre who are not known to have a genetic mutation should be offered an assessment of their 10-year breast cancer risk using a validated risk assessment tool (for example Tyrer-Cuzick or BOADICEA)(16,17) to assess whether they are or will be eligible for MRI. MRI surveillance should be offered annually when indicated: From 30–39 years: • to women at a 10-year risk of greater than 8% From 40–49 years: • to women at a 10-year risk of greater than 20%, or • to women at a 10-year risk of greater than 12% where mammography has 3 shown a dense breast pattern . Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 18 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Women who have not been tested but have a high chance of carrying a BRCA1 or TP53 genetic mutation should be offered annual MRI surveillance from 30–49 years if they are at: • a 50% risk of carrying one of these mutations in a tested family, or • a 50% risk of carrying a BRCA1 or TP53 mutation in an untested or inconclusively tested family with at least a 60% chance of carrying a BRCA1 or TP53 mutation (that is, a 30% risk of carrying one of these mutations themselves). MRI and any accompanying mammography data should be collected for audit purposes to support a national database. For the purposes these calculations, a woman’s age should be assumed to be 30 years of age for a woman in her thirties and 40 years of age for a woman in her forties. A 10-year risk should then be calculated for the age range 30–39 and 40–49, respectively. A 10-year risk of 8% aged 30–39 and a 10-year risk of 12% risk aged 40–49 years would be fulfilled by women with the following family histories: • 2 close relatives diagnosed with average age under 30 years* • 3 close relatives diagnosed with average age under 40 years* • 4 close relatives diagnosed with average age under 50 years* *All relatives must be on the same side of the family and one must be a mother or sister of the woman Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 19 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 6 Results 6.1 Current surveillance system Women with a family history of cancer access the current system of surveillance through their general practitioner and the cancer genetics network for Wales. Once an individual’s risk is estimated through ascertainment of their family pedigree they can be offered genetic testing and surveillance as appropriate. The patient journey from awareness of family history to annual mammographic surveillance is described in figure 2. Women can cease surveillance at any time by withdrawing their consent in writing. These women will still receive an invitation to join the breast screening programme age 50 years. Women will also cease the programme if they move out of Wales or have a bilateral mastectomy. Figure 2. Patient journey in current surveillance programme. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 20 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Source: Breast Test Wales Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 21 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Epidemiology of women currently offered surveillance. The Family History Programme began in 2001. Since then 2363 women have been registered in the programme, 1080 assessed as at high risk of developing breast cancer due to their family history, and the remainder at moderate risk. Women with a lifetime risk of breast cancer greater than 15% are classified as at moderate or high risk. Those women who in addition have a heterozygote risk of more than 25% are classified at high risk. 6.1.1 Age range Women registered in the programme are aged between 30 and 65 years, and are offered screening according to the protocol described in the previous section. Eligibility for screening depends on a woman’s age and risk status. Women registered with the programme can decline screening and thus the number registered with the programme varies from the number of screens performed in a year. Women return to the population breast screening programme after the age of 50 for those assessed at moderate risk, and after the age of 60 for those assessed at high risk. The median age of women registered on the programme at high risk is 42 years, and at moderate risk is 47 years (Figure 3). Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 22 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Figure 3. Women registered in the family history programme by age and risk category. Women registered in the family history program by age and risk, All Wales. (2007) 600 Number 500 400 High risk 300 Moderate risk 200 100 0 30-34 35-39 40-44 45-49 50-54 55-59 60-64 Age (years) 6.1.2 Area of residence By end November 2007, a total of 596 women were registered on the programme in the northern division with approximately equal numbers in high and moderate risk categories (310 and 286 respectively), 791 in the western division (340 high risk and 451 moderate risk) and 952 (430 high risk and 522 moderate risk) in the southern division (Figure 4). Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 23 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Figure 4. Women registered in the family history programme by region and risk category, November 2007. Women registered in the family history program, by region and risk category (2007) 600 Number 500 400 High risk 300 Moderate risk 200 100 0 North South West Region 6.1.3 Trends over time Since the programme was initiated in 2001, there has been a steady yearly increase in the number of mammographic screens offered and performed for the women registered in the family history programme. Figures 5 & 6. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 24 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Figure 5. Screens performed each quarter for women in the family history programme, 2001 – 2007. 500 400 300 South 200 West 100 North 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Number of screens performed Screens performed for women in the Family History program (2001- 2007) Wales 2001 2002 2003 2004 2005 2006 2007 Year Figure 6. Annual number of screens performed for women in the family history programme, 2001 to 2006. Annual total number of screens performed for women in the family history program, 2001 to 2006 Number of screens performed 1600 1400 1200 South 1000 West 800 North 600 All Wales 400 200 0 2001 2002 2003 2004 2005 2006 Year Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 25 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 The number of mammographic screens performed for women on the family history programme has risen in all divisions since the programme started in 2001. The total number of screens for Wales has risen from 129 in 2001 to 1431 in 2006. 6.2 Expected number of women registered in the Family History Programme following NICE guidance implementation The guidance states that MRI surveillance should be offered annually to women from 30–39 years for those at a 10-year risk of greater than 8%, and from 40–49 years for those at a 10-year risk of greater than 20%, or at a 10-year risk of greater than 12% where mammography has shown a dense breast pattern. In addition, women who have not been tested but have a high chance of carrying a BRCA1 or TP53 genetic mutation should be offered annual MRI surveillance from 30–49 years if they are at a 50% risk of carrying one of these mutations in a tested family, or a 50% risk of carrying a BRCA1 or TP53 mutation in an untested or inconclusively tested family with at least a 60% chance of carrying a BRCA1 or TP53 mutation (that is, a 30% risk of carrying one of these mutations themselves). The Welsh Cancer Genetics Service assesses women on their lifetime risk using Cyrillic software. Women are classified as high risk, moderate risk or population risk. For the purpose of estimating the number of women requiring annual MRI surveillance in Wales, the NICE guidance is equivalent to recommending that all women assessed as high risk by the AWCGS require annual surveillance from 30 years and all women assessed as moderate risk require annual MRI surveillance from 40 years(18). Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 26 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 At age 50, women assessed at moderate risk would then join the population screening programme, and those women of assessed as high risk would be offered 18 monthly mammography to age 60 years before rejoining the population screening programme, as is currently the case in the Family History programme. At present approximately 1500 mammographic screens are performed annually for women aged between 35 and 60 years who are at moderate and high risk of breast cancer due to their family history. All of these women would be eligible for annual MRI surveillance and so the same number of MRI scans would be performed annually. Women with TP53 gene mutations currently receive annual MRI surveillance on an ad hoc basis outside of BTW. These women need to receive annual breast MRI surveillance from 20 years, and this would add a further 10 MR scans to the annual total. These women would not receive mammograms due to their inherent radio sensitivity. The age of first screening for high risk women, under the NICE guidance, would be reduced from 35 to 30 years. This would generate an approximate additional 100 screens per annum for high risk women. In addition there are approximately 100 women who currently receive annual mammography outside of the BTW service within the symptomatic service. These women have had their risk assessed through the All Wales cancer genetics service and would be eligible for annual MRI surveillance. Finally, epidemiology suggests that 1% of the population of England and Wales are at high risk of breast cancer due to inherited factors and 9-13% are at moderate risk(4). Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 27 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 This suggests that 25 – 30% of women eligible for annual surveillance are not currently known to the service. In total there would be a need for 1700 MRI scans per annum for women known to the service at present, and between 2000 and 2200 MRI scans per annum if women not currently known to the service were recruited. 6.3 Current MRI scanners in Wales There are currently 15 MRI scanners in Wales (Figure 7). Twelve of these have sufficient field strength to perform breast imaging to the standards specified by the Royal college of Radiologists(2), RCR, (Appendix 1). Ten have the capacity to perform breast biopsy under MRI, were biopsy equipment purchased. A further four scanners will be installed by the end of 2008 which meet the RCR standard, and which will have breast biopsy capability. This brings the total number of scanners capable of MR breast imaging and biopsy to 14. Although ten scanners could be used for biopsies, at present only one site in Wales perform MR guided breast biopsy, this being Ysbyty Gwynedd in north west Wales. 6.3.1 Ability of current MRI Scanners to meet identified need A breast MRI takes 30 minutes, but time needs to allowed between scans for patients to enter the scanner and equipment be cleaned (15 minutes), reporting the scan takes approximately 15 minutes by a radiologist who specialises in breast imaging(2). Initially scans will take longer to read until expertise and experience is gained in Wales. Scans ideally are to be dual read. A MRI scanner can work for 250 days per Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 28 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 year, allowing for weekends and bank holidays. A further 8 days are planned for maintenance and up to 2% (5 days) unplanned down time is normally specified in a NHS contract. This means that at optimum usage a MR scanner can perform a maximum of 10 breast scans per day, 237 days per year. These scans must be scheduled between days 6 and 16 of the woman’s menstrual cycle due to the changes in the MR appearance of breast tissue during the cycle. The number of scans needed to provided surveillance to women already known to the family history programme is 7 to 8 per day across Wales, allowing for <10% recall, and if provision is to be made for the current unmet need then this figure rises to 9 to 10 MR scans per day across Wales, allowing for 10% recall. In addition, some of the women scanned will have lesions visualized which require biopsy. Approximately 60% of lesions identified by MR can be seen and biopsied by second look ultrasound. Ultrasound biopsy is preferable where possible due to its increased patient acceptability, speed and reduced cost over MR biopsy. It is not known how many MR guided biopsies will be indicated for this patient group, and MR guided breast biopsy is a specialised skill at the present time. It’s clear that identified need couldn’t be met from within the existing MRI resource. This is confirmed by the recent review of diagnostic imaging(19)(3), which concluded that there is not the capacity in Wales to meet current targets without investment in workforce and equipment. The review specifically states that additional further investment would be necessary for provision of new services such as breast MRI surveillance. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 29 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Figure 7. Location of current MRI scanners in Wales and capability to perform MR guided breast biopsy 9 14 12 8 15 11 7 13 6 17 18 2 16 1 4 3 19 5 10 Key on page 30. Source: Welsh Health Estates Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 30 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Key to figure 7. Number 6.4 Location Ability to do biopsy Currently performs by end 2008 MR breast biopsy 1 Princess of Wales Yes No 2 Neath Port Talbot Yes No 3 UHW1 Yes No 4 UHW2 Yes No 5 Llandough (CAVOC) Yes No 6 Prince Phillip Yes No 7 West Wales General Yes No 8 Bronglais No No 9 Glan Clwyd No No 10 Royal Gwent No No 11 Nevill Hall No No 12 Wrexham Maelor No No 13 Prince Charles Yes No 14 Ysbyty Gwynedd Yes Yes 15 Withybush Yes No 16 Royal Glamorgan No No 17 Morriston Yes No 18 Singleton Yes No 19 Velindre Yes No Comparative surveillance systems No comparative surveillance systems were found in a review of the literature. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 31 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust 7 Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Options for provision Possible options for provision of MRI breast surveillance in accordance with NICE guidance 41 were identified through discussion with stakeholders and presented for discussion at the Breast Test Wales Annual General meeting, 28th February 2008. Stakeholders consulted are listed in the appendix 2. 7.1 MRI in Breast Test Wales In this model, women after assessment by the All Wales cancer genetics service would be registered in the family history programme at BTW. BTW would oversee the call/recall system of women according to the recommendations made in NICE guidance 41. Women would receive mammography; MRI with the option of MR or ultrasound, guided biopsy of detected lesions as clinically indicated. Women would receive all surveillance imaging at one centre, delivered with continuity of care by the BTW team. Surveillance would take place in BTW centres based in the three divisions: North; West; and South. MRI, USS and mammography would be to NHS Breast Screening Programme standards and quality assured. MRI and any accompanying mammography data would be collected centrally for audit purposes to support a national database. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 32 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Specialist radiologists; radiographers; and administrative support would be employed by BTW. 7.2 Acute Trusts In this model, women after assessment by the All Wales cancer genetics service would be referred to a breast specialist in a breast unit within a trust. The surveillance service could be provided In all acute trusts with imaging capability, or Three trusts designated regional breast surveillance units. Call/recall would be overseen by the trust appointment system. Women would receive mammography; MRI with the option of MR or ultrasound, guided biopsy of detected lesions as clinically indicated. Women would receive all surveillance imaging at one trust, and clinical review by the breast specialist. MRI, USS and mammography would need to be to nationally agreed standards, in line with NHS Breast Screening Programme standards, including the dual reading of films. MRI and any accompanying mammography data would need to be collected for audit purposes to support a national database. 7.3 Breast Test Wales/ Acute trust hybrid In this model, after assessment by the All Wales cancer genetics service women would be registered in the family history programme BTW. BTW would oversee the call/recall system of women according to the recommendations made in NICE Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 33 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 guidance 41. Women would receive mammography at one of the BTW centres, and breast MRI with the option of MR guided or ultrasound guided biopsy of detected lesions at a breast unit within a trust. The MRI surveillance service could be provided In all acute trusts with imaging capability, or Three trusts designated regional breast surveillance units. MRI, USS and mammography would be to NHS Breast Screening Programme standards and quality assured through systems in place within BTW. MRI and any accompanying mammography data would be collected centrally for audit purposes to support a national database hosted by BTW. Specialist breast radiologists and administrative support would be employed by BTW, and MRI scanner time and radiographer support purchased from the acute Trust. 8 Appraisal 8.1 Call/recall The management of a secure, systematic surveillance programme requires that a central list of patients is collated and managed effectively, with efficient processes for regular update and removal of patient details. Central call and recall is even more important for screening programmes, which depend on the issuing of fixed appointments in order to maximise throughput of equipment and optimise capacity within limited skilled staff. In addition to these requirements, MRI surveillance of women under 50 years requires the scans to be coordinated with the appropriate time in the woman’s menstrual cycle and appointments issued need to include the opportunity to reschedule if the timing is inappropriate. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 34 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Central coordination of call/ recall avoids dead time during the working day due to unfilled slots, and enables the surveillance round length to be maintained. This approach also allows standardisation of patient letters and information; optimisation of capacity of radiographic and clinical staff and equipment; and coordination of imaging and results allowing timely referrals to symptomatic services where necessary as well as synchronization of each programme component, so that invitations are issued smoothly throughout the year. BTW not only has the capacity and expertise to operate a centralized call/recall system, but has a proven track record in operating such systems. 8.2 Radiology expertise Breast imaging is a specialty within radiology, which requires between 6 and 12 months subspecialty training. Breast MRI is a specialist field in which not all radiologists are experienced, and the RCR breast group recommends that in order to remain competent radiologists should read more than 50 breast MR scans per year. MRI guided breast biopsy is not widely practiced in Wales, and current expertise would need to be expanded to provide optimal MRI surveillance for this group of women. In order for clinical skills to be maintained breast MRI would need to be concentrated in a few centres of breast imaging excellence rather than dissipated across all acute trusts. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 35 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust 8.3 Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Staffing BTW and symptomatic breast services employ radiologists with a specialist interest in breast imaging. The trusts, but not BTW, in addition have radiographers with the technical skills to perform MRI. BTW, but not trusts, has administrative support staff with expertise in operating specialist call/recall systems and the coordination of the surveillance process. BTW, within its current staffing capacity, performs annual mammographic assessment, and biopsy of lesions where indicated, for women registered in the family history programme. BTW receives no funding for operating this service. However staff would need to be recruited in addition to those already employed due to the number of additional MRI scans needed, and the potential for the number of women registered in the family history programme to increase. Recruitment of additional specialist staff is applicable to trusts and BTW in order to operate the surveillance programme. 8.4 MR capacity A MRI breast screening examination is a complex examination that needs to be performed to a specified minimum standard. Centres providing MRI breast screening should meet specified standards relating to equipment, protocol and interpretation, and should participate in audit. Minimum and expected standards are recommended Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 36 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 for equipment, sequences, contrast and reading of examinations. It is anticipated that symptomatic examinations will also be performed to the same high quality. BTW does not have MRI scanners and current centres do not have the physical capacity to easily accommodate such new equipment. Although several trusts have MRI scanners capable of performing breast imaging and biopsy. There is not the capacity within the system to provide the additional number of scans necessary to operate the surveillance programme for women with a family history of breast cancer. If NICE 41 guidance is to be implemented in Wales new MRI capacity will have to be created. 8.5 Standards and quality assurance Quality assurance is a fundamental part of the NHS Breast Screening Programme, (NHSBSP). The aim of quality assurance in the NHSBSP is to maintain minimum standards and to improve the performance of all aspects of breast screening in order to ensure that women have access to a high quality breast screening service wherever they live. The NICE guidance states that where mammographic imaging is indicated, it is to be done to NHSBSP standards. NICE guidance also states that breast MRI is to be performed to high quality standards. Further the RCR Breast group sets out the standards for MRI breast surveillance and for symptomatic breast MRI. BTW has experience of quality assuring a national service and participates in the UK QA coordinators group. BTW already operates mammographic examinations to the NHS Breast Screening Programme standards for women in the Family History Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 37 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 programme, and is ideally placed to quality assure the MRI surveillance for these women. 8.6 Access Women registered with the Family History Programme are distributed across the whole of Wales. In order to provide an equitable and accessible surveillance programme it is necessary to create MRI capacity in each of the three regions, North, South and West, similar to the current BTW screening model. Although women resident in remote rural areas may still have comparative difficulty in accessing specialist centres, this model minimizes those difficulties without compromising the quality of the clinical service. 9 Recommendations Investment in new MRI scanners and the specialist staff necessary to operate a surveillance programme is imperative in order to implement NICE guidance 41. The best model of provision combines the experience and expertise of BTW in managing a call/recall system and operating quality assured screening services, with the capacity of the trusts to accommodate new MRI scanners and utilize their full capacity. Three centres for breast surveillance are needed to ensure equality of access to the surveillance service. These would ideally be situated in specialist breast units in the North, South and West of Wales, allowing surplus MRI capacity to be utilised in symptomatic breast services. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 38 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Consideration must be given to the cost of options such as mobile or breast only MR scanners, and developments in digital mammography, such as tomo-synthesis when commissioning this service. These were not within the remit of this report. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 39 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust 10 Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Reference List (1) National Institute for Health and Clinical Excellence. Familial breast cancer. The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care. Clinical guidance 41. London: NIHCE; 2006. Available at: http://www.nice.org.uk/CG41 [Accessed 16th June 2008] (2) Royal College of Radiologists Breast Screening Group. UK MRI breast screening protocol. 2006. [website]. Available at: http://www.rcrbreastgroup.com/MRI/MRIScreeningStandards.php [Accessed 16th Jun 2008] (3) Office for National Statistics. Cancer trends in England and Wales, 1950-1999. Studies on Medical and Population Subjects 2001; 66. (4) McPherson K, Steel CM, Dixon JM. ABC of breast diseases. Breast cancerepidemiology, risk factors, and genetics. BMJ 2000; 321(7261):624-8. (5) NHS Cancer Screening Programmes and Cancer Research Campaign. Familial breast and ovarian cancer: an information pack for primary care. London: DoH; 2001. (6) Peto J, Mack TM. High constant incidence in twins and other relatives of women with breast cancer. Nature Genetics 2000; 26:411-4. (7) Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of earlyonset breast cancer. Implications for risk prediction. Cancer 1994; 73: 643-51. (8) Ford D, Stratton M, Narod S, Goldgar D, Devilee P, Bishop DT et al. The Breast Cancer Linkage Consortium: Genetic Heterogeneity and Penetrance Analysis of the BRCA1 and BRCA2 genes in breast cancer families. American Journal of Human Genetics 1998; 62:676-89. (9) Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53 297 women with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Lancet 1996; 347:1713-27 (10) R&D Office of the Anglia & Oxford NHS Executive and the Unit for Public Health Genetics C. Report of consensus meeting on the management of women with a family history of breast cancer. 1998. (11) Department of Health. Interim advice to GPs on familial breast cancer. London: DoH; 2000. Available at: Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 40 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPoli cyAndGuidance/DH_4008593 [Accessed 16th Jun 2008] (12) Hill AD, Doyle JM, McDermott EW, O'Higgins NJ. Hereditary breast cancer. British Journal of Surgery 1997; 84:1334-9. (13) Lalloo F, Varley J, Ellis D, O'Dair L, Pharoah P, Evans. DGR and the early onset breast cancer study Group. Family history is predictive of pathogenic mutations in BRCA1, BRCA2 and TP53 with high penetrance in a population based study of very early onset breast cancer. Lancet 2003; 361:1011-12. (14) National Institute for Health and Clinical Excellence. Clinical guidelines for the classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care. CG014. London: NICE; 2004. Available at: http://www.nice.org.uk/guidance/index.jsp?action=download&o=30253 [Accessed 16th Jun 2008] (15) Leach MO et al. Screening with magnetic resonance imaging and mammography of a UK population at high familial risk of breast cancer: a prospective multicentre cohort study (MARIBS). Lancet 2005; 365:1769-78. (16) Amir E et al. Evaluation of breast cancer risk assessment packages in the family history evaluation and screening programme. Journal of Medical Genetics 2003; 40, 807-14. (17) Antoniou A et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case Series unselected for family history: a combined analysis of 22 studies. American Journal of Human Genetics 2003; 72:1117-30. (18) National Institute for Health and Clinical Excellence. Familial cancer. The classification and care of women at risk of familial breast cancer in primary, secondary and tertiary care. Quick reference guide. London: NIHCE; 2006. Available at: http://www.nice.org.uk/nicemedia/pdf/CG41quickrefguide1.pdf [Accessed 16th Jun 2008] (19) National Public Health Service for Wales. Predicting future demands for MRI and CT scanning in Wales. A horizon scan. Cardiff: NPHS; 2008. Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 41 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Appendix 1. UK MRI Breast screening protocol A Magnetic Resonance Imaging (MRI) breast screening examination is a complex examination that needs to be performed to a specified minimum standard. Centres providing MRI breast screening should meet specified standards relating to equipment, protocol and interpretation, and should participate in audit. Minimum and expected standards are recommended below for equipment, sequences, contrast and reading of examinations. It is anticipated that symptomatic examinations will also be performed to the same high quality. A UK working party met to form a consensus on what might be expected in a UK MRI unit. The multidisciplinary group comprised members of the Magnetic Resonance Imaging breast study (MARIBS) steering group, representatives from industry including MR manufacturers and software companies producing tools for use in breast MRI analysis. The members and affiliations are listed. This document is on the Royal College Radiologists Breast Group web site for consultation. Equipment MRI system High field modern MRI machine should be used when undertaking breast MR Minimum standard 1T Expected standard > or = 1.5T Comment – evidence from 3T should be assessed to ensure same quality is achieved with higher field system Breast coil Dedicated bilateral breast coil to be used for examinations (either open or closed) Uniform signal homogeneity across coil Number of elements Minimum standard: 2 channel Expected standard: > or = 4 channel MRI sequences Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 42 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 T1W dynamic set. Fat saturation is preferred to image subtraction if good fat saturation can be achieved within the recommended acquisition time. > or = one pre-contrast. Acquire for >6 minutes post contrast T2W fat suppressed high resolution or STIR (Short Tau Inversion recovery) Higher resolution pre and post contrast T1W with fat saturation 0.6mm minimum in plane-resolution. 50% improvement in voxel size compared with dynamic unless already achieved in the dynamic series. These are not required if the dynamic series achieves 0.6mm resolution or better. In a surveillance exam, need: Voxel size ≤ 2mm Dynamic sequence ≤ 60 sec Total exam time ideally <30 mins Minimal motion Integrated fat suppression – desirable in dynamic series where achievable Examine both breasts – ideally with isotropic voxels Uniform signal homogeneity across image Slice thickness Bilateral breast examination should be undertaken with high resolution to achieve small lesion detection Minimum standard: ≤ 2.5mm Expected standard: ≤ 2mm In plane resolution Expect high resolution in plane resolution Minimum Standard <1.3 mm Expected standard <1.0 mm Acquisition time Dynamic contrast examination is required to detect abnormal enhancing lesions to improve specificity Minimum standard: ≤ 60 secs dynamic acquisition Expected standard: ≤ 45 secs acquisition Fat suppression A fat suppression technique should be used to improve lesion conspicuity. This can either be an integral aspect of the contrast enhanced sequence or obtained by using a subtraction technique Minimum standard: subtraction Expected standard: integrated fat suppression Breast movement Breast movement should be minimised during the procedure in order to obtain best quality and dynamic data Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 43 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Minimum standard: support of breasts to minimise motion Expected standard: as above Contrast Pump injection of at least 0.1mmol/kg contrast is recommended with 3ml/sec flow rate with 20ml bolus saline Initiate start of post contrast exam to time centre of k space at 20 secs post injection UK recommendations on avoidance of contrast reactions and Nephrogenic Systemic Fibrosis should be followed. Image registration An image registration technique should be used if motion artefact is a problem during the examination Hormonal Factors Timing of examination The examination should be carried in the mid portion of the menstrual cycle to reduce normal parenchymal tissue enhancement. Minimum standard: Time examination to day 6-16 of the menstrual cycle Hormone Replacement Therapy (HRT) There is some evidence that HRT increases parenchymal enhancement. However there is no evidence to suggest that stopping HRT reduces normal glandular tissue enhancement. Breast Biopsy Where possible repeat targeted breast Ultrasound (US) and review of mammograms is recommended. Where lesion is not seen on conventional imaging referral to a recognised MR breast biopsy centre is advised. Reading recommendations When reporting MRI it is recommended the following information is included in the report: type of image acquisition, breast density, lesion type – morphology, size, enhancement pattern, size of lesion in 3 dimensions, assign score ( score 1-5: 1 normal, 2 benign, 3 probably benign, 4 suspicious of malignancy, 5 malignant). Minimum standard – include information as listed above Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 44 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Expected standard - standardized report ( to be developed with UK lexicon, and linked to BIRADS) Mammograms – It is recommended that all relevant imaging is available when reporting MRI , especially for symptomatic referrals. Audit should be undertaken to ensure that reporting accuracy and biopsy rates are acceptable. As yet no standards have been agreed. Double reporting –where possible reports should be made by two radiologists who are familiar with breast MRI. There is little evidence for reporting experience but the following is suggested: Minimum standard – 30 cases/year, second opinion sought where necessary Expected standard - > or = 50 cases/year, double reporting where possible. Screening recall standards Recall rate A minimum number of women should be recalled for further imaging or biopsy Minimum standard <10% Expected standard <7% Data Import Minimum standard is uncompressed DICOM 3.0 Data should be written to a CD directly from the scanner/workstation and not via PACS (some centres have reported that data has been rescaled by PACS). If using PACS then a QA process should be in place to ensure that the source data has not been modified DICOM compliance It is expected that all modern MRI machines and workstations will be DICOM compliant - Minimum and Expected standard PACS Integration Minimum standard – QA process should be in place to ensure no alteration of the source data. Viewing Tools It is important to have good analysis tools available on the reporting workstation. These will include - Subtraction/MPR/MIP software, signal enhancement analysis package with ROI tools. Hotspot analysis for diagnosis – max SI, Guidance on scaling - air/fat?), software package to support image analysis, image registration features, ability to change display of images Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 45 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Minimum standard – as above Expected standard – as above together with pharmacokinetic modelling, ROI Pixel by pixel analysis with wash-in and wash-out maps. Working party members Fiona J Gilbert, Professor of Radiology, University of Aberdeen Martin Leach, Professor of Imaging, Institute of Cancer research Anwar Padhani, Consultant Radiologist, Mount Vernon, London Lindsay Turnbull, Professor of Radiology, University of Hull Ruth Warren, Consultant Radiologist, Addenbrookes, Cambridge Emma Hurley, Consultant Radiologist, South Manchester University Hospitals Preminda Kessar, Consultant Radiologist, Bromley Hospitals Will Teh, Consultant Radiologist, North West London Hospitals Erica Scurr, Superintendent Radiographer, The Royal Marsden NHS Foundation Trust David Collins, MR Physicist, Institute of Cancer research Martin Graves, MR Physicist, University of Cambridge Gary Liney, MRI Physicist, Hull Royal Infirmary Geoff Parker, Senior Research Fellow, University of Manchester Linda Pointon, MARIBS Co-ordinator, Institute of Cancer Research Gek Kwan-Lim, MARIBS Research Manager, Institute of Cancer Research Emillie Bryant, Scientific Officer, Institute of Cancer Research Andreas Muehler, President, CAD Sciences Henry Wyszomierski, Chief Technology Officer, CAD Sciences Raymond Joslin, Chairman, CAD Sciences Mary Gatewood, Confirma Daniel White, Confirma Bart Maertens, Confirma Elga Grimes, MR Application Specialist, GE Healthcare Dylan Pritchard, GE Healthcare Trevor Furniss, Sales Manager UK & Eire, Invivo Elizabeth Moore, MR Applications Specialist, Philips Medical Systems David Clark, MRI Applications Specialist, Siemens Medical Solutions Patrick Revell, Siemens Medical Solutions Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 46 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Appendix 2. Stakeholders consulted Name Role Location Dr. Diane Brook Director of Information SE Wales Ms Ann-Marie Chandler Patient Representative North Wales Dr. Jonathan Davies Consultant Radiologist West Wales Dr Rosemary Fox Programme Manager SE Wales Dr. Andy Gash Consultant Radiologist North Wales Dr. Kate Gower-Thomas Consultant Radiologist SE Wales Mrs Julie Grier Genetic Counselor North Wales Mr. Ian Monypenny Consultant Surgeon SE Wales Dr Alex Murray Consultant Geneticist SE Wales Mrs Pamela Parkhouse Patient Representative SE Wales Dr Mark Rogers Consultant Geneticist SE Wales Mr Andrew Ward Diagnostic imaging engineer, Welsh SE Wales Health Estates Dr Phillipa Young Consultant Radiologist Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 47 of 50 SE Wales Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Stakeholders at BTW AGM presentation and discussion, 28th February 2008. Name Role Location Dr. Bethan Bayley Breast Physician North Wales Mrs Catherine Bennett Radiographer Reader SE Wales Dr. Jane Blethyn Consultant Radiologist SE Wales Mrs Susan Brady Breast Care Nurse North Wales Dr. Diane Brook Director of Information SE Wales Dr. Jane Brook Assoc. Spec. Breast Physician SE Wales Dr Philip Brumwell Consultant Histopathologist SE Wales Dr. Tony Caslin Consultant Pathologist North Wales Dr. Carrie Champ Consultant Pathologist SE Wales Mr Richard Cochrane Consultant Surgeon North Wales Dr. Margaret Cotter Consultant Pathologist SE Wales Mr. Derek Crawford Consultant Surgeon North Wales Dr. Nick Dallimore QA Consultant Pathologist SE Wales Mrs Jayne Daniels Breast Care Nurse West Wales Mrs Louise Davidson Breast Care Nurse SE Wales Dr. Jonathan Davies Consultant Radiologist West Wales Dr. Jenny Deeble Consultant Radiologist West Wales Dr. Anthony Douglas- Consultant Pathologist Jones SE Wales Mrs Tina Edmunds Radiographer Reader SE Wales Dr. Kim Edwards Consultant Radiologist North Wales Dr. Elizabeth Edwards Assoc. Spec. Breast Physician SE Wales Dr. Nest Evans Consultant Radiologist SE Wales Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 48 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Dr Rosemary Fox Programme Manager SE Wales Dr. Andy Gash Consultant Radiologist North Wales Mr. Christopher Gately Consultant Surgeon SE Wales Dr. Kate Gower-Thomas Consultant Radiologist SE Wales Mr Sumit Goyal Consultant Surgeon SE Wales Dr Tom Hockey Consultant Pathologist SE Wales Mr. Simon Holt Consultant Surgeon West Wales Dr Jonathan James Consultant Radiologist Nottingham Mrs Delyth Jones Radiography Reader West Wales Mr Nader Khonji Consultant Surgeon West Wales Mr Minn Lwin Consultant Surgeon North Wales Mr. William Maxwell Consultant Surgeon West Wales Mr. Ian Monypenny Consultant Surgeon SE Wales Meleri Morgan Consultant Pathologist SE Wales Dr. Ciaran O'Brien Consultant Pathologist West Wales Dr. Meena Powell Consultant Radiologist North Wales Mrs Catherine Richards Breast Care Nurse SE Wales Dr Mark Rogers Consultant Geneticist SE Wales Dr. Vasha Shah Consultant Pathologist SE Wales Miss Helen Sweetland Consultant Surgeon SE Wales Dr Vidya Upadhyaya SpR in Radiology North Wales Mr. Eifion Williams Vaughan- Consultant Surgeon SE Wales Dr. Anne Wake Consultant Radiologist SE Wales Dr. Sidney Wan Consultant Radiologist SE Wales Dr. Wynne Williams Consultant Pathologist (Singleton) West Wales Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 49 of 50 Status: Final version Intended Audience: CSCG breast group Public Health Division – Velindre NHS Trust Options for provision of MRI surveillance in Wales to women with a family history of breast cancer as recommended in NICE guidance 41 Mr. Rhodri Williams Consultant Surgeon SE Wales Mrs. Bethan Williams Advanced Practitioner West Wales Reference List (1) Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53 297 women with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Lancet 1996; 347:1713-1727. (2) R&D Office of the Anglia & Oxford NHS Executive and the Unit for Public Health Genetics C. Report of consensus meeting on the management of women with a family history of breast cancer . 1998. Ref Type: Report (3) National Public Health Service. Predicting future demands for MRI and CT scanning in Wales: A horizon scan. 2008. Ref Type: Report Author: J.L.Cartwright, SpR Public Health Version: 2 Date02/07/08 Page: 50 of 50 Status: Final version Intended Audience: CSCG breast group