5.1 Familial Breast cancer

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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
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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
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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
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Status: Final version
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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
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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
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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
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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
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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).
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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.
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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
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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).
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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).
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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
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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.
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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
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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.
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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.
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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
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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.
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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.
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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
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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
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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
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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.
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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
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The classification and care of women at risk of familial breast cancer in
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Office for National Statistics. Cancer trends in England and Wales, 1950-1999.
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(6) Peto J, Mack TM. High constant incidence in twins and other relatives of
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(7) Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of earlyonset breast cancer. Implications for risk prediction. Cancer 1994; 73: 643-51.
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(10) R&D Office of the Anglia & Oxford NHS Executive and the Unit for Public
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women with a family history of breast cancer. 1998.
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London: DoH; 2000. Available at:
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Date02/07/08
Page: 40 of 50
Status: Final version
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group
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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
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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,
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[Accessed 16th Jun 2008]
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Author: J.L.Cartwright, SpR Public Health
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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
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


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
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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
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