HMRI Imaging Centre

Users Guide Researchers and Clinicians

Contents 1.0 Introduction

3

1.1

3

Advancing Translational Research in MRI

1.1.1 Siemens AG 3T Prisma MRI scanner

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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

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5.0 Ethics

8

6.0

Safety Information

9

6.1

Contrast Usage Guidelines

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7.0 Contacts

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8.0

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HMRI Imaging Centre Floor Plan

Attachment A – Access Application Form and Terms and Conditions

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Attachment B - Procedure for the Management of Incidental Findings on Research MRI Scans

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Attachment C – MRI Safety Questionnaire

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Attachment D – HMRI Imaging Centre Induction Checklist

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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 [email protected] 2.17 Should any person be concerned about any activities occurring in the HMRI Imaging Centre they should contact HMRI Facilities Management at [email protected] 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 [email protected] 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 [email protected].



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 [email protected] 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 [email protected]. 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 [email protected]. 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: [email protected] 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: [email protected] 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 (