HMRI Imaging Centre
Users Guide
Researchers and Clinicians
Contents
1.0Introduction
3
1.1
3
Advancing Translational Research in MRI
1.1.1 Siemens AG 3T Prisma MRI scanner
3
1.1.2 NordicNeuroLab AS fMRI Hardware System
3
1.2
Benefits to Patients
3
2.0
Standard Operating Procedures (SOPs) and Unit Rules
4
3.0
Codes of Conduct
5
3.1
Code of Conduct - Researchers
5
3.2
Code of Conduct – Participants and Patients
5
4.0
Gaining Access
6
4.1
Scanner Hours of Operation
6
4.2
Scanner Costs 6
4.3
Access Procedure
6
4.4
Approved/Ongoing Projects
6
4.5
Scan Booking Procedures
6
4.6
Carpark Bookings
6
4.7
Conclusion of Booking
7
4.8
Cancellation of Bookings
7
5.0Ethics
8
6.0
Safety Information
9
6.1
Contrast Usage Guidelines
9
7.0Contacts
10
8.0
11
HMRI Imaging Centre Floor Plan
Attachment A – Access Application Form and Terms and Conditions
12
Attachment B - Procedure for the Management of Incidental Findings on Research MRI Scans
15
Attachment C – MRI Safety Questionnaire
17
Attachment D – HMRI Imaging Centre Induction Checklist
18
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1.0 Introduction
The $6 million HMRI Imaging Centre was officially opened in March 2014. With the acquisition of a Siemens
Magnetom Prisma 3 tesla scanner, shared between research and clinical usage, this gives University of
Newcastle medical researchers and local medical practitioners priority access to world-leading technology.
Located adjacent to the HMRI Building on the John Hunter Hospital campus, the facility improves research
capabilities by making functional MRI (fMRI), diffusion tensor imaging (DTI), MR spectroscopy, and clinical
imaging available in a single location. The MRI scanner is state-of-the-art, is the only one of its kind in the
Southern Hemisphere and places HMRI and the University of Newcastle in a unique position world-wide.
The new centre also promotes a translational research environment, allowing for more conducive collaboration between basic
science researchers working with pre-clinical models and researchers conducting MRI imaging on human subjects and patients.
Because of this, the integrated MRI research programs are expected to have even more impact. Scientists who discover a
breakthrough application of MRI for treating disease in pre-clinical models can rapidly share their findings with clinicians and
researchers working with human subjects.
The Prisma system has multi-transmit technology as well as 64 receiver channels and dedicated coils for brain, breast, prostate,
extremity, and body imaging. The Prisma allows researchers and clinicians to measure brain structure and function, as well
as connectivities and chemistry in a non-invasive manner. It is also capable of non-invasively assessing functional measures
associated with cancer and monitoring these same measures during cancer treatments. While the facility is within the Hunter
Medical Research Institute, it is run as a core University facility. The facility is managed on a daily basis by the Faculty of Health and
Medicine with oversight provided by the Centre’s Management Committee. The HMRI Imaging Centre Scientific Review Committee
reviews new project proposals and advises on future equipment acquisitions.
1.1
Advancing Translational Research in MRI
Magnetic Resonance Imaging (MRI) is an essential research tool for the non-invasive study of both the biological structures and functions of the human body. MRI Imaging in pre-clinical models can be used to understand disease processes and develop novel treatment approaches. Human MRI studies build upon this, allowing a unique view of virtually every organ of the body. From the study of brain function in neuropsychiatric disease to the measurement of pulmonary physiological parameters, to new image-guided therapy approaches, the use of innovative MRI methods is revolutionising biomedical science.
1.1.1
Siemens AG 3T Prisma MRI scanner
This Prisma has a number of features that enhance image quality, acquisition speed, and work flow productivity. These
improvements allow for a greater range of novel research applications. With specially designed magnetic gradient coils the Prisma is capable of high spatial resolution investigations of structural and functional connectivity of the human anatomy
including brain functionality, body physiology, organ morphometry and tissue metabolism.
1.1.2 NordicNeuroLab AS fMRI Hardware System
Sensory perception studies are the basis for many research studies that use fMRI. The HMRI Imaging Centre is equipped with a fully integrated array of fMRI hardware for auditory and visual stimulus presentation, response collection, and experiment synchronisation.
1.2
Benefits to Patients
The cutting edge research at the HMRI Imaging Centre will deeply impact a wide range of diseases and potential treatment applications. Some areas of active investigation include:
• Brain diseases (psychiatric disorders, degenerative neurological diseases, neurosurgical applications, and traumatic
brain injury)
• Advanced imaging of ischaemic stroke, and investigations of brain function during stroke rehabilitation
• Investigation of the chemical composition of normal and diseased tissues and organs with MR spectroscopy.
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2.0 Standard Operating Procedures (SOPs) and Unit Rules
2.1
The main purpose of the HMRI Imaging Centre is for internal University of Newcastle and HMRI research. However,
clinically referred patients may be also be scanned under an agreement with Hunter New England Local Health District
and Hunter New England Imaging.
2.2
All scanning of human subjects must be undertaken by qualified diagnostic radiographers with appropriate training in MRI
scanning, (see Appendix C – “MRI Safety Training Program Outline” in “HMRI Imaging Centre, Magnetic Resonance Imaging
(MRI), Safety Procedures and Guidelines Manual”).
2.3
All scannees will be escorted from HMRI Reception to the HMRI Imaging Centre.
2.4
The HMRI Imaging Centre MRI scanner will not be used in the diagnosis of emergency clinical cases.
2.5
The MRI scanner will not be used for interventional MRI procedures unless specific approval has been granted from
University of Newcastle HREC and the Hunter New England Local Health District.
2.6
The MRI scanner presents many safety risks, some potentially lethal, to scanned participants as well as staff and visitors in
its near vicinity. Accordingly, safe operation of the MRI facility shall always be accorded the highest priority in fulfilment
of University of Newcastle OH&S obligations as well as ethical requirements for participants. A detailed health and safety
risk assessment for the MRI facility is provided in “HMRI Imaging Centre, Magnetic Resonance Imaging (MRI), Safety
Procedures and Guidelines Manual”.
2.7
Mandatory work instructions for ensuring the safety of participants, staff and visitors to the Imaging Centre are specified in
Sections 5-11 of the “HMRI Imaging Centre, Magnetic Resonance Imaging (MRI), Safety Procedures and Guidelines Manual”.
2.8
Only those scan procedures that have been approved by the Human Research Ethics Committee for that study and/or
research procedure are to be undertaken on individual participants.
2.9
Gadolinium chelates, used for contrast-enhanced scans, will only be administered by Hunter New England Imaging certified
radiologists or medically qualified physicians.
2.10 The MRI scanner will be operated in normal and 1st level control mode. It will not be operated in 2nd level control mode
unless specific HREC approval has been granted, (see Appendix J “HMRI Imaging Centre, Magnetic Resonance Imaging
(MRI), Safety Procedures and Guidelines Manual”).
2.11 All completed scans will receive a “duty of care” radiology report with results sent to the nominated chief investigator.
2.12 Staff and users not directly involved in the current scanning session will leave the control room upon completion of their
imaging session to preserve participant privacy.
2.13 The Data Analysis room is for data analysis only and will not be used as office space or for permanent occupation.
2.14 The HMRI Imaging Centre will operate a day shift, (9am – 5pm) on week days.
2.15 Access to the Imaging Centre outside of routine operating hours requires prior approval from the Management Committee.
2.16 Should any person be concerned about any aspects of these guidelines please contact hmri-imagingcentre@newcastle.edu.au
2.17 Should any person be concerned about any activities occurring in the HMRI Imaging Centre they should contact HMRI
Facilities Management at fm@hmri.com.au to make their concerns known.
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3.0 Codes of Conduct
3.1
Code of Conduct - Researchers
3.1.1 All research trials will be conducted in accordance with the NHMRC National Statement on Ethical Conduct in Human
Research (2013), must have gained ethics approval from an accredited Human Research Ethics Committee and have all
requisite safety approvals prior to commencement.
3.1.2 Researchers will maintain a professional manner and presentation.
3.1.3 In accordance with Health Service guidelines, fully enclosed liquid impermeable shoes (preferably leather) are to be worn at
all times with heeled shoes up to 4 cm (no stilettos) permitted.
3.1.4 Researchers are to commence and finish their appointments on time and to work in a timely manner.
3.1.5 Researchers are to adhere to the HMRI Imaging Centre booking system; are not to book scans unnecessarily and are to
cancel all bookings that are no longer required.
3.1.6 The privacy of participants is to be protected. Change room doors are to be kept closed during appointments.
3.1.7 All shared equipment used during MRI studies should be cleaned and returned to its storage area immediately following use.
3.1.8 Used and soiled linen will be placed in dirty linen baskets at the completion of each imaging session.
3.1.9 Any repeated breach of operational guidelines will be notified to the Management Committee and researchers will forfeit
their right to access the facility.
3.2
Code of Conduct – Participants and Patients
3.2.1 Research participants and clinical patients are to be escorted through the corridors of the HMRI Building and HMRI Imaging
Centre at all times.
3.2.2 Children must be appropriately supervised by an adult at all times.
3.2.3 The eating of food is to be actively discouraged in the magnet room, data analysis work room, EEG room, and waiting areas,
unless it is applicable to the study testing; or in specific circumstances such as infant feeding or children being allowed to
snack during appointments. Any food scraps are to be disposed in the general waste bins.
3.2.4 All participants are to report to HMRI Reception on level 4 on arrival where they will be asked to sign in and complete the
“MRI Safety Screening Questionnaire” whilst waiting in the Clinical Trials Waiting Area. Participants should also be asked to
sign out at Reception following their visit.
3.2.5 All participants and patients must conduct themselves in a safe, orderly and respectful manner.
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4.0 Gaining Access
4.1
Scanner Hours of Operation
Standard operating hours for the HMRI Imaging Centre are from 9:00 a.m. to 5:00 p.m., Monday through Friday.
4.2
Scanner Costs
The current 2016 rate for scanner usage is $600 per hour and includes a MRI radiographer to run the scanner. Other
supplies (e.g. contrast agents or any further staffing requirements) will incur additional fees. Scanner time is allocated in 30 minute increments.
4.3
Access Procedure
If you have a new project that needs discussion, or you have not yet used the system, we suggest contacting Saad Ramadan
or hmri-imagingcentre@newcastle.edu.au in the first instance.
If you have specific requirements for your scanning procedures (e.g. coils, sequences) you may be referred to the senior radiographer for assistance.
Scanning cannot proceed without appropriate research ethics clearances (see section 5) or without approved funding for the cost of the scans.
A completed HMRI Imaging Centre Access Application (see Attachment A) along with signed Terms and Conditions should be submitted to hmri-imagingcentre@newcastle.edu.au.
Upon receipt, the application will be forwarded to the Scientific Review Committee for review and prioritisation. The Scientific Review Committee will review and prioritise the project based on; innovation, feasibility of project, development
required to implement project and availability of personnel and equipment. Notification of access will occur within two weeks.
All users of the facility are required to attend the MRI Safety Induction Course before using the MRI scanner. Users must attend the course to enter the MRI control room.
4.4
Approved/Ongoing Projects
Once approved by the Scientific Review Committee projects will be assigned a project reference number that can be used to schedule time, billing and for any other project queries.
As an initial review measure of the HMRI Imaging Centre facility, a project report will be requested after the conclusion of the
study to provide analytics on the following:
• Number of subjects studied
• Status of data analysis
• Papers submitted based on data
• Grants submitted based on data.
4.5
Scan Booking Procedures
Proposed times and dates should be emailed to hmri-imagingcentre@newcastle.edu.au noting specific study number.
All MRI scan bookings will be made via the Bookings Clerk and entered into Hunter New England Imaging (HNEI) Radiology
Information System (RIS). The Bookings Clerk will confirm in writing (email) the booked time slots within one week of
receiving the request.
Daily bookings will be displayed in the MRI Control Room Area and a copy held at HMRI Reception.
Each scannee will be scanned with their assigned medical record number (MRN) recorded at the time of scanning.
Specific exclusion of certain scannees are listed in Section 8 – Actions for Contra-indications of the “HMRI Imaging Centre MRI Safety Procedures and Guidelines Manual”.
4.6
Carpark Bookings
Bookable carpark spaces may be reserved for HMRI Imaging Centre participants via HMRI Reception. The participants
name should be identified when the booking is made.
On arrival at the HMRI carpark boomgate, participants should use the intercom to notify Security for access to the carpark; and must then park as per instructions from HMRI Security.
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4.7
Conclusion of Booking
Clinical contact rooms and spaces for data analysis must be left in a clean and orderly state for the next booking.
It is the responsibility of each user of the Imaging Centre to clean and leave the facility in a tidy state, appropriate for the next user.
Linen must be removed after each use and placed in the linen trolley. Clean linen will be provided in the Equipment and Store Room but should only be taken to the clinical contact rooms for an established need. Linen is not to be placed routinely in Contact rooms, in an endeavour to ensure the cleanliness of linen for each occasion of use.
Any facility consumables that have been used up or are running low are to be restocked. Alert the Senior MRI Radiographer if stocks are low or have been depleted.
4.8
Cancellation of Bookings
Researchers are required to cancel any booking which is not required at least 24 hours prior to the scan time.
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5.0 Ethics
No scanning can proceed until appropriate research ethics has been obtained. The primary Human Research Ethics Committees for this facility are the University of Newcastle HREC and the Hunter New England Health (HNEH) HREC.
All scans are read by a radiologist and receive a ‘duty of care’ radiology report. You will therefore need to indicate in your ethics application the process by which you will deal with an adverse finding. This includes making sure that each research subject consents in writing to their radiology report being released to the researcher who is named as being responsible for report follow-up. See also Procedure for the Management of Incidental Findings on Research MRI Scans (Attachment B).
For further information on the University of Newcastle HREC refer to:
HREC - About Us
Application Forms, Guidelines and Procedures
Human Research Involving University of Newcastle and Hunter New England Health Procedures
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6.0 Safety Information
The MRI magnet is ALWAYS on. This means no person is allowed to enter the MRI scan room without clearance
and permission from a certified MRI radiographer. Metallic objects (such as fingernail clippers, pocket knives
and even pens) can lead to serious bodily injury if brought within the magnetic field.
Projectiles are one of the biggest dangers associated with the MRI scanning environment and occur when the strong magnetic fields of the MRI magnet attract ferromagnetic (metal) objects which then become airborne. Even small objects such as paperclips or scissors can be quickly jerked from your hands and severely injure anyone nearby. Metallic objects in
the body can also have dangerous effects when placed in a magnetic field. Some metal implants, including some metal fragments, may move inside the body causing internal injury.
All potential MRI research subjects must be screened for items that may be hazardous to themselves or others prior to entering the MRI scan room. It is strongly recommended that anyone involved in the recruitment of MRI research subjects include all items from the MRI Safety Questionnaire (Attachment C) when screening subjects.
All users of HMRI Imaging Centre must attend the MRI Safety Induction course prior to research commencing. Attendance at the course is mandatory for all MRI users wishing to be permitted into the MRI control room. For information on the next scheduled MRI Safety Induction course, please email hmri-imagingcentre@newcastle.edu.au.
All personnel using the HMRI Imaging Centre are to have completed the HMRI Imaging Centre Staff and User Induction Training (Attachment D). Additionally, all personnel using the HMRI Imaging Centre are to be inducted into the HMRI Building. These inductions may be conducted by experienced users nominated from each research group. The HMRI Induction checklist should be requested from fm@hmri.com.au.
6.1
Contrast Usage Guidelines
Follow RACR and TGA guidelines:
•
Screen patients prior to administration of gadolinium-based contrast agents to identify those with acute kidney injury or chronic, severe, kidney disease. Use the clinical history to screen patients for features of acute kidney injury or risk factors for chronically reduced kidney function. The minimum allowable GFR measurement for all subjects receiving contrast is 60.
• Blood serum levels prior to contrast injection
• Monitor for signs and symptoms of Nephrogenic Systemic Fibrosis after gadolinium-based contrast agents are administered to a patient suspected or known to have impaired elimination of the drug.
•
Advise subjects with kidney disease to contact a healthcare professional if any of the following symptoms occurs after
receiving a gadolinium-based contrast agents: burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.
• Record the specific gadolinium-based contrast agents and the dose administered to a patient.
• When administering gadolinium-based contrast agents, do not exceed the recommended dose. Prior to any
re-administration, allow sufficient time for elimination of the gadolinium-based contrast agents from the body.
• For further and more comprehensive information, refer to the HMRI Imaging Centre MRI Safety Procedures and
Guidelines Manual.
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7.0 Contacts
All enquiries should be directed to: hmri-imagingcentre@newcastle.edu.au in the first instance.
FACULTY OF HEALTH AND MEDICINE
Ms Elaine Terry - Associate Director, Faculty Services
Dr Saad Ramadan - Facility Manager
Ms Shirley Savy - Research and Research Training Officer
MANAGEMENT COMMITTEE
Professor Kevin Hall
Professor Michael Nilsson
Ms Elaine Terry
Dr Saad Ramadan
Ms Shirley Savy (Secretary)
SCIENTIFIC REVIEW COMMITTEE
Professor Mark Parsons
Professor Robert Callister
Dr Saad Ramadan
EMERGENCY CONTACT INFORMATION
For any Medical Emergency at the HMRI Imaging Centre
Call 000
HMRI Security Services – 4042 0007
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HMRI Imaging Centre
8.0 Floor Plan
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Appendices
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APPENDIX A
HMRI Imaging Centre
Access application form
Complete and return entire form to: hmri-imagingcentre@newcastle.edu.au
PROJECT DETAILS
Chief Investigator
Contact Number/s
Email Address
Project Title
Ethics Approval Number
Provide the names and
Institutions (if other
than UON) of the other
Investigators listed on the
project
Provide a short project
description (<500 words).
Please include scanner
and coils to be used and
required sequences
All access requests will be reviewed by the HMRI Imaging Centre Scientific Committee prior to confirmation of bookings.
BILLING DETAILS (Only complete one option for billing - Internal Transfer or Invoice)
Internal Transfer
UON Cost Collector
Cost Collector Owner
Faculty
School
Name of person to be
invoiced
Invoice
Address to where invoice is
to be sent (including email
address)
Please specify any other
requirements to be listed on
the invoice
*Please note that a Purchase Order number must be provided before scans can be booked/confirmed.
SCAN CONTACT DETAILS
Requester Name
Contact Number/s
Email Address
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APPENDIX B
HMRI Imaging Centre - Access application form
INTERNAL OFFICE USE ONLY
PROPOSED
START DATE
SCAN DETAILS
PROPOSED
FINISH DATE
DATE
TIME
TOTAL
(ExGST*)
Estimated total:
* GST is charged for research scans where external billing is required. No GST is charged for internally billed research scans or clinical scans.
All standard scans in 2016 will be charged at $600 per hour unless otherwise agreed.
INTERNAL OFFICE USE ONLY
Scans Scheduled
Yes
No
Date:
Booking Confirmation emailed
Yes
No
Date:
Processed by
Terms and conditions
(Must be read, authorised and emailed with Access Application Form)
The University of Newcastle, in conjunction with the Hunter Medical Research Institute (HMRI) offers access to
the Prisma Clinical Research MRI Scanner for those who have ethics approval and the approved funds to pay for
access. As time on the scanner becomes restricted, access to the facility will be based on scientific merit. The
primary human research ethics committee for most projects will be the University of Newcastle HREC.
Application and Approval
Forward your completed access applications to: hmri-imagingcentre@newcastle.edu.au. Applicants will be notified within two
weeks on the status of their application.
Protocol Development
Researchers seeking time on the scanner must schedule an appointment with the senior radiographer, prior to submission of an
access application, to discuss the availability of protocols and hardware. At the time of the appointment applicants should indicate
whether their project will require any developmental scanning or whether it will involve “off the-shelf” sequences.
While the majority of sequences on the scanner are product sequences provided by the vendor, these sequences will usually be
made available upon software version upgrade(s).However, work in progress (WIP) and customer-to-peer (C2P) sequences are at
risk of being voided as a result of software upgrade(s) and researchers must take this risk into consideration during the planning
phase of the imaging protocol. The Imaging Centre is NOT responsible for researcher’s inability to use WIPs or C2P sequences due
to software upgrade(s).
Health and Safety
Health and Safety is paramount to the operations of the HMRI Imaging Centre and its partners. All researchers who access the
scanner are required to comply with all health and safety policies, guidelines and procedures (including induction) applicable to the
operation of a MRI scanning facility.
Staffing
To ensure the utmost safety of participants and researchers, staffing on all projects within the HMRI Imaging Centre will include:
• Participants not requiring contrast: two radiographers or one radiographer and researcher/medically qualified doctor
• Participants requiring contrast: two radiographers and one radiologist or medically qualified doctor
• Phantoms: one radiographer
Once your Access Application form is approved, staffing requirements will be confirmed for your project.
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HMRI Imaging Centre - Access application form
Transportation of Patient Participants
Research participants who are current inpatients need to be medically stable and not currently undergoing any treatments (i.e. no
IV lines or IV bags to ensure MRI comparability), in order to be transported safely to the HMRI Imaging Centre. They will need to be
transported preferably by wheel chair and accompanied by a physician and attendant (holder of first aid certificate).
Radiologist Report
For research studies, it is the responsibility of the researcher to inform the participants in the study that the radiologist report may be
limited based on the sequences performed. A full clinical MRI scan may be required should there be a concern and additional costs
may be incurred. It is also the responsibility of the researcher to check RIS (Radiology Information System) to access available duty
of care reports on a regular basis.
Cost
Scanning costs will be $600 per hour for 2016, unless otherwise agreed based on scope* of project. Cost includes one
radiographer and between the facility hours of Monday to Friday, 9am to 5pm. Scans outside of these hours will incur an additional
fee. One free human scan to establish correct protocols and sequencing is available prior to commencement (up to one hour
duration). A discounted rate can be negotiated for a full day’s usage – requests should be emailed to hmri-imagingcentre@
newcastle.edu.au.
*Scans requiring contrast, sequences and/or coils that are not ‘off the rack’ will incur additional fees. Scanning rates are subject to annual review at
the start of each calendar year (1 January).
Billing
Researchers who have elected to cover costs utilising UON administered grant funds will be informed monthly of their usage and
the funds will be transferred from their nominated internal research account.
If the applicant and/or funding source is external to the University, a tax invoice will be sent to the nominated person. Terms are full
payment within 30 days upon receiving the invoice.
Bookings
Once a completed Access Application Form is approved by the Scientific Review Committee, scan bookings can be made by
emailing date and time requests to hmri-imagingcentre@newcastle.edu.au.
Bookings for large blocks of time, e.g. a complete week, will require four week’s notice with a non-refundable deposit of $500. The
deposit will be offset on the costs of the scans once they have taken place.
The HMRI Imaging Centre will endeavour to accommodate all research scans (including those that are advised at short notice)
providing there is capacity within the day’s booking and during the current hours of operation.
Cancellations
Cancellations must be made at least 24 hours prior to the scheduled time or the full scan costs will be charged. Late arrival will
cause cancellation of the scan and the time billed. It is the responsibility of the researcher, not the Imaging Centre, to remind or
confirm that participants will be attending their allocated scan time.
Data Management
The Imaging Centre does not have the facilities to archive and store data. Data generated from scans can only be held for 48 hours
within the Centre. It is the responsibility of the researcher to access the data and ensure the management and security of data after
this 48 hour period.
Agreement
I, the undersigned, as Chief Investigator of this study agree to be bound by these terms and conditions and I am aware of, and will
comply with, the University of Newcastle Responsible Conduct of Research Policy – 000873.
Name:
Signature:
Project:
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Date:
APPENDIX C
HMRI Imaging Centre
Procedure for the Management
of Incidental Findings on Research
MRI Scans
1.0 PURPOSE
1.1 This procedure sets out guidelines and protocols for Chief Investigators managing incidental radiological findings on research scans performed at the HMRI Imaging Centre.
2.0 BACKGROUND
2.1
Most MRI scans undertaken at the HMRI Imaging Centre are for research purposes only and not for diagnostic or therapeutic purposes. Participants in research can be either healthy with no history of any medical illness or diagnosed with some disorder/disease. The scans performed on healthy participants are often routine and without any abnormalities. However, albeit rarely, some abnormalities may show that are of clinical concern. These occurrences are known as incidental findings.
3.0 SCOPE
3.1 Participants undergoing research scans are identified.
3.2 Ensure guidelines for reporting incidental findings are in place and adhered to.
3.3 Procedures on the management of incidental findings are followed.
3.4 Unless specified, the HMRI Imaging Centre will provide safety reads as standard procedure. Upon application, a comprehensive radiologist report can be requested (additional fees will apply).
4.0 PROCEDURES
4.1 All research scans undertaken at the HMRI Imaging Centre will be reported by a certified Hunter New England Imaging (HNEI) qualified radiologist.
4.2 The radiologist report will be available on RIS within two weeks of the scan date.
4.3 It is the responsibility of the CI to get access to RIS or CAP from their local area health district.
4.4 The report is to be sent to the Chief Investigator/primary physician of the study in hard copy within three weeks of scan date.
4.5 The CI is to document and file the report until the study is complete or until the standard length of the relevant research
record is to be held.
4.6 The radiologist report will be part of the medical records held under the relevant local health district.
4.7 The HMRI Imaging Centre will keep records of incidental findings and will follow up with the CI to ensure that the necessary follow-up steps have been taken, within two months of the report being issued.
HEALTHY PARTICIPANTS
4.8 The CI is responsible for checking on the report on a regular basis (weekly).
4.9 If an abnormality is found, the CI must follow procedures for incidental findings outlined in the Information Statement of
approved Ethics application. In the absence of an appropriate procedure, the CI is required to inform the participant of the
findings and advise them to seek further recommendations from their GP within 14 days of receiving the report.
4.10 All researchers should include a letter of disclosure in their consent to all participants to the effect of how an abnormal finding in a study is managed (a sample from reference 8.1 is attached in Appendix)
4.11 The radiologist who reported the scan will be available to discuss the findings with the relevant GP should this be needed in order for the latter to take appropriate management.
RESEARCH PARTICIPANTS
4.12 The primary physician is responsible for reviewing and discussing the report with the participant in a timely manner.
4.13 If the findings are outside the scope of the project and/or specialty of the primary physician, it is the duty of the primary physician to consult or refer the patient to appropriate clinical colleagues in a timely fashion.
4.14 If necessary, the radiologist who reported the scan will be available to discuss the findings with the primary physician in order for the latter to make appropriate clinical decisions.
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APPENDIX C
HMRI Imaging Centre - Procedure for the Management
of Incidental Findings on Research MRI Scans
5.0 GENERAL
5.1 The HMRI Imaging Centre will NOT be responsible for any additional costs that are incurred from the investigations resulted from either the safety read or comprehensive report.
5.2 Any additional costs incurred by the researchers or the participant will not be covered in the scan fee.
6.0 DEFINITIONS
6.1
Safety Read
Involves a review of structural sequences obtained as part of a research study. The radiologic assessment will be standardised to a single line report unless gross abnormalities (as determined by the reporting radiologist, such as the presence of a large tumour, bleed, etc) are demonstrated. The safety read cannot be used for diagnostic purposes and the participant may require further clinical scans as advised by their primary physician.
The routine safety report may resemble “study within normal limits” or, if there is something of clinical significance, a brief description and a clinical scan may be recommended for further assessment.
6.2
Comprehensive Radiologist Report
Involves a review of structural scans obtained as part of a research study. The report will include a comprehensive assessment of the structures and comment as directed by the participant’s clinical background (e.g. stroke, multiple sclerosis). It is expected that this report can be used as part of further clinical management of the participant.
The participant may require additional scans with or without the use of contrast medium to further investigate the problem as advised by their primary physician.
6.3 Healthy Participant
Refers to any person who has volunteered to participate in a MRI scan and does not have a known clinical condition of specific scientific interest.
6.4 Research Participant
Refers to any person who has volunteered to participate in a MRI scan and also has a known clinical condition of specific research interest.
7.0 ABBREVIATIONS
HMRI Hunter Medical Research Institute
MRI Magnetic Resonance Imaging
HNEI Hunter New England Imaging
CI Chief Investigator
GP General Practitioner
RIS Radiology Information System
CAP Clinical Applications Portal
8.0 REFERENCES
8.1 Discovery and Disclosure of Incidental findings in Neuroimaging research, 2006, Illes et al, Journal of Magnetic Resonance Imaging
8.2 Policy Concerning Human Subjects Research at the Dana and David Dornsife Cognitive Neuroscience Imaging Center
8.3 Protocols for Incidental and Adverse MRI Findings and Release of MR Images to Participants, Monash Biomedical Imaging, Melbourne
9.0 APPENDIX
Letter of Disclosure (reference noted at 8.1)
“The MRI scan being done is designed to answer research questions, not examine you medically. This MRI scan is not a substitute for one a
doctor would order. It may not show problems that would be picked up by a clinically performed MRI scan. All our scans will be reported by a
doctor who is trained in the reading of MRI scans, a radiologist. If the radiologist thinks that there may be an abnormality in your MRI scan,
we will contact you and will help you get medical follow-up for the problem. If you have a primary care doctor or GP, we can contact your
doctor, with your permission, and help him or her get the right follow-up for you. All information generated in this study will become part of a
hospital record routinely.”
17 - HMRI Imaging Centre - Users Guide
APPENDIX D
HMRI Imaging Centre
MRI Safety Questionnaire
Patient name:
Date of birth:
Weight:
kg / stone
Height:
cm / feet-inches
WARNING: Due to the MRI system having a very strong magnetic field that is always on, it may be inappropriate/ hazardous for some
individuals to have a scan. Therefore all questions must be answered accurately to determine your eligibility. Incorrect information could result
in serious injury. If you do not fully understand any of the questions please ask for help.
Have you ever had an operation of any kind, at any time in your life?
Yes
No
If yes, list all operations, approximate dates, and mark the operation areas on the figure opposite.
Have you had an MRI examination before?
If yes, when and where?
Yes
No
Do you have any of the following? (Please tick yes or no for all questions)
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
Cardiac pacemaker / defibrillator / pacing wires
Artificial heart valve
Aneurysm clip
Ear implant (e.g. stapes, cochlear) / bionic ear
Vascular implant / stent / coil / filter / aortic graft
Neurostimulator or drug infusion pump
Electronic or magnetically activated implant or device
Brain shunt
Any other type of prosthesis / implant (eye, penile, etc)
Right
Left
If you answer yes to any of these questions, please call 4042 0905 prior to your booking
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Joint replacement or artificial limb
Metal rods, plates or screws in/on bones
Metal / shrapnel / bullet injuries
Hearing aid
Have you ever been a metal worker? (e.g. welding, grinding, lathe)
Have you ever had metal in your eye following an injury or operation? If yes, has it been removed?
Yes
Is there any possibility of metal in your body through injury or surgery, other than that stated on this sheet?
Do you have a history of kidney (renal) disease?
Have you ever had an allergic reaction to contrast media?
Do you suffer from claustrophobia?
Is there any possibility you could be pregnant?
False teeth / removable bridgework
Body piercing
Tattoos
Nicotine or medication patches
Do you have liver failure?
Are you diabetic?
Are you breastfeeding?
Have you filled out and understood all questions on this form?
No
I hereby confirm that I have read, understood and correctly answered the above questions and agree to have an MRI and procedures necessary
to complete the examination
Signature of person completing form:Date:
Form completed by:
Patient
Relative
Doctor
Other (please specify)
Print name and contact number/ page number
WARNING: Before entering the scan room all metallic objects must be removed including watches, jewellery, hearing aids, wallet, credit cards,
coins, keys, pens/pencils, scissors, mobile phones, hair pins, clips, piercings, clothing with metal e.g. bra, jeans, zips, studs. Lockers available.
MRI OFFICE USE ONLY
Form information reviewed by, and first time out identification:
Second time out identification by:
18 - HMRI Imaging Centre - Users Guide
Signature Designation
Signature Designation
APPENDIX E
HMRI Imaging Centre
Induction Checklist
This form is designed to induct new personnel into the HMRI Imaging Centre.
This induction shall occur before the person commences work in the Centre.
Inductees can be asked to verify they have received this information and confirm that they have understood it by way of questioning
and demonstration. This checklist represents a part of your record of induction, and should be returned to HMRI reception.
DETAILS
Name
Research Group
Extension No.
Email Address
Mobile No.
First alternate
contact
Second alternate
contact
Extension No.
Extension No.
Mobile No.
Mobile No.
Induction date:
Inducted by:
I have read and understood the HMRI Imaging Centre’s Safety Procedures and Guidelines Manual and agree to abide by these
guidelines during my activities within the Imaging Centre.
Signature:
INDUCTION ITEM or PROCEDURE
Review contents of HMRI Imaging Centre Guidelines
Completion of HMRI building induction
Access requirements
Room booking procedure
Car park booking procedure
Evacuation procedures
Emergency procedures booklets
Use of spill kits
First aid kit / first aiders
Registration in HMRI first aid course
Location of duress alarms
Location of consumables
Waste disposal procedures
Hand-washing procedures
Operation of shared clinical equipment
Computer use
Location of, and introduction to, reception
Location of, and introduction to, security
19 - HMRI Imaging Centre - Users Guide