908 MRI

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) ensures correct and safe use of the MRI for data collection conducted under the supervision of the Clinical & Translational Research Unit (CTRU). Attachment templates include:

A: MRI Screening Form, B: MRI Scan Tracking Log

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Definitions

Magnetic Resonance Imaging (MRI): MRI is a technique that uses strong magnetic fields and radio waves to image tissues, organs, and internal structures. The orientation of the image is controlled by varying the magnetic field using gradient coils. As these coils are rapidly switched on and off, they create the characteristic repetitive noises of an MRI scan. The contrast between different tissues is determined by the rate at which excited atoms return to the equilibrium state.

Procedures

1. Operator Training

• To be delegated as an authorized MRI user, a person must undergo training and demonstrate competency for independent use. The training will be provided by a designee of the CTRU leadership consisting of physics of MRI, performing standard protocols, safe use of the equipment, participant screening, and participant safety. In addition, a representative from Esaote, a Radiologic Technologist (RT), or another licensed person will conduct an on-site training session on the specific use of the Esaote MRI unit. A trainee will perform at least three MRI testing sessions under supervision. There could be a cost associated with becoming an authorized user.
• An authorized MRI operator must demonstrate competency in the proper screening procedures, the potential side effects of MRI, monitoring and reporting of adverse events, and operation of the hardware and software of the MRI machine. The operator will also be able to answer any questions concerning the safety and/or general basics of MRI raised by subjects.

2. Equipment Inspection and Timelines

• Regularly scheduled maintenance is performed as part of the Esaote service provider agreement.

3. Safety

• MRI does not use ionizing radiation and there are no known harmful side effects associated with temporary exposure to the magnetic field. However, there are important safety concerns to consider before performing an MRI scan.
  • Contrast agents are not to be used in CTRU MRI procedures.
  • The magnet may cause pacemakers, artificial limbs, and other implanted medical devices that contain metal to malfunction or heat up during the exam.
  • Any loose metal object may cause damage or injury if it gets pulled toward the magnet.
  • Dyes in tattoos and tattooed eyeliner can cause skin or eye irritation.
  • Medication patches with foil backing can cause a skin burn and may cause excessive release of medication if they are heated.
  • The wire leads used to monitor electrophysiological systems during a scan must be placed carefully to avoid causing a skin burn. The scan could also interfere with the signal.
  • Prolonged exposure to radio waves during the scan could lead to slight warming of the body.
• Due to these safety considerations, all subjects must complete the MRI screening form prior to the scan. If the subject answers ‘YES’ to any question, the operator must not proceed with the scan until receiving approval from the CTRU Medical Director or his/her designee.
• There is no lower or upper age limit for MRI scans in the CTRU; however, any subject must be able to lie still and adhere to the protocol without sedation, or with minimal assistance of one person.
• For research subjects, a urine pregnancy test may be administered to all females of childbearing age or pregnancy status will be assessed per the study protocol without documentation of sterilization.
• Results will be recorded on the subject’s MRI screening form. Anyone with a positive pregnancy test will be informed of their result, advised to contact their personal physician, and if the woman is a research subject, the principal investigator (PI) will be notified. Anyone with a positive pregnancy test will not receive an MRI scan.

4. MRI Procedures

• Make sure the scanner is fully calibrated before the subject’s arrival. See manufacturer’s manual for general calibration procedures.
• Record the calibration result in the QC logbook. If the scan is for a research project, the operator must verify that the subject has a participant identification number.
• Explain the procedure to the subject and ask if they have questions before proceeding with the exam.
• All subjects must complete and sign Attachment A: MRI Screening Form before each session. If the subject answers ‘YES’ to any question the operator must not proceed until receiving approval from the CTRU Medical Director or his/her designee. If there is any uncertainty concerning safety, the subject should not participate in the scanning session.
• Have the subject remove jewelry, body piercings, hearing aids, glasses, clothing with zippers or metal buttons, and bra, and change into scrubs. Underpants are the only thing that may be worn underneath the scrubs.
• Clothing and valuables are to be locked. Give the key to the subject to keep for the duration of the exam.
• Use the ferromagnetic detection device prior to the participant entering the room with the MRI scanner, to ensure that the participant does not have any metallic objects on him or her.
• If it is not in the direct area being scanned, a piercing that cannot be removed must be taped.
• Position the subject on the MRI table according to the study protocol and explain the scan procedure again, instructing the subject to remain still during the entire exam.
• If the subject expresses discomfort, dizziness, signs of nervousness, and/or indicates a desire to withdraw from scanning or stop the procedure, assess the situation, and take appropriate steps to ensure subject safety. These may include requesting assistance from CTRU staff, notifying the PI, and/or terminating the procedure.
• Each scan must be recorded on Attachment B: MRI Scan Tracking Log with the Date, Participant ID, Study Name or Number, PI Name, and Technician Name.

5. MRI Image Acquisition Guidelines

• Consistency:
  • If serial exams are to be performed, parameters used for the prior imaging sessions must be kept consistent for all follow-up imaging. Scanner and subject positioning must remain consistent from visit to visit for each subject, especially with respect to resolution (matrix size and slice thickness) and slice positioning.
  • Save protocol/parameters on the MRI system so that the same parameters can be used throughout the study with each subject at every time point.
• Binding:
  • When blinding is required, images must be free of marks or annotations, including analysis of regions of interest.
• Archival:
  • It is the investigator’s responsibility to save all imaging data (Digital Imaging and Communications in Medicine; DICOM) on a blank CD media for secondary backup.
• Deviations:
  • The images must be acquired in strict adherence to guidelines. Deviations must be reported in a timely manner to the PI.

6. Cleaning Procedures

• Disinfect all surfaces with CaviWipes® (or industry equivalent) after each procedure, using appropriate personal protection equipment.
• If blood or organic liquids have come into contact with the surfaces of the unit:
  • Decontaminate all contaminated surfaces thoroughly with mild detergent or CaviWipes® (or industry equivalent)
  • Disinfect the decontaminated surfaces with CaviWipes® (or industry equivalent)
• Use liquid and spray cleaning agents with caution. Conductive liquids that drip onto the equipment components may cause a short circuit and a risk of fire.
• Never use organic solvents to clean the system or use the system in the presence of such substances if they are flammable.

7. Emergency Procedures

• In an emergency, it is possible to block the radio frequency impulses and the generation of the magnetic field as described below. NOTE – THIS DOES NOT QUENCH THE MAGNET. THE MAGNET IS PREMANENTLY ON.
  • Right click in Output (the bottom white space from where you run the sequences) <Scan> of the user interface and select <Abort → All> in the context menu displayed. This interrupts all queued scans. OR
  • On the control panel, select the command <Emergency> displayed alongside. In this case all sequences in progress and queued are terminated and the system is rotated to the horizontal position (if set to an angle other than 0 degrees). The power supply to the amplifiers and motor is then shut off.
  • After the command <Emergency> is selected, the system is not ready for a new examination until the operation configuration is reset.
  • Pressing <Emergency> and (where necessary) rotating to the horizontal position automatically logs off the user.
  • Following this, log on and press <OK> when the first dialog window displays the message <The Emergency key has been pressed. Proceed with system function restore>. Then press <OK> when the next window displays the message <System operation restored>. The system is then ready for a new examination.
• Accidental Shutdown, damage to PC, or Power Failure
  • Press <Emergency> twice; the first time to activate the control panel (and consequently the emergency key) and the second time to rotate the system to zero degrees.
• Fire
  • An extinguisher specifically tested and approved for use in magnetic resonance must be kept on site. Use of the wrong type of fire extinguisher, such as one with a steel cylinder, can cause electric shock or projectile effects.
• Medical Emergency
  • Use non-magnetic assistive devices as necessary, such as an aluminum or polyethylene backboard. If emergency personnel (fire, public safety) need to enter the MRI room, they must follow all standard safety procedures and remove all metal objects.

8. Other Important Information

• Make sure the examination room's condition is within the optimal range. G-scan Brio must operate in an environment with a temperature range of 20-26°C (68-79°F), with variations no greater than ±3°C/hour. If there is a warning message regarding temperature of the magnet, running any of the one-hour-long protocols might resolve the issue since it could elevate the temperature of the magnet. Report on the occurrence of the CTRU Director.
• Correct subject positioning, scan acquisition, and consistency at follow-up visits are key to obtaining reliable assessments. Anatomical positioning, coverage, and imaging parameters should remain consistent across all imaging visits for any given study subject. Values obtained at pre-treatment determine the point from which change is measured. Therefore, pre-treatment scans must be performed in accordance with the guidelines described above especially with respect to resolution (matrix size and slice thickness) and slice positioning, and each follow-up scan must adhere to positioning and acquisition relative to the pre-treatment scan.
• For technical problems call the Esaote service engineer or the Esaote help desk (1-800-927- 0708). Obtaining an error log message from the user interface by screen capture or by taking a photograph could be helpful for the technician to resolve the issue.

9. Suggested Informed Consent Language

MRI (Magnetic Resonance Imaging)

MRI machines use a strong magnet and radiofrequency magnetic fields to make images of the inside of the body. You will be asked to lie on a long table for a certain amount of time [state how long] while the machine gathers data. The scanning procedure is like an X-ray or CT scan but there is no radiation involved. Rather, there will be a strong magnetic field and radiofrequency magnetic fields, which you will not feel. You will hear repetitive tapping noises that arise from the Magnetic Resonance (MR) scanner. We will provide earplugs or headphones that you may wear. People occasionally feel somewhat confined when they are lying on the table although we have taken many steps to relieve the "claustrophobic" feeling.

Risks: Magnetic fields do not cause harmful effects at the levels used in the MRI machine. However, the MR scanner uses a very strong magnet that will attract some metals and affect some electronic devices. If you have a cardiac pacemaker or any other biomedical device in or on your body, it is very important that you tell the MRI operator and others on the study team. As metallic objects may experience a strong attraction to the magnet, it is also very important that you notify the operator of any metal objects, devices, or implants that are in or on your body before entering the magnet room. All such objects must be removed (if possible) before entering the magnet room. In some cases, having those devices means you should not have an MRI scan performed. In addition, watches and credit cards should also be removed as these could be damaged. You will be provided with a way to secure these items. A researcher or MRI operator will review safety information with you before the scan. To determine whether it is safe for you to undergo the scanning procedure it will be important that you tell the researchers about any metallic objects or devices in, or on, your body. If you have any history of head or eye injury involving metal fragments, if you have ever worked in a metal shop, or if you could be pregnant, you should notify the operator and members of the study team. If you have tattoos or permanent make-up, you may feel these areas getting warm during the scan and you should notify the MRI operator if this occurs.

There is a possibility that you will experience a localized twitching sensation due to the magnetic field changes during the scan. This is expected and should not be painful. Dizziness or nausea may occur if your protocol involves changing positions to or from the weight-bearing mode.

IF YOU FEEL DISCOMFORT AT ANY TIME, NOTIFY THE OPERATOR. YOU CAN DISCONTINUE THE EXAM AT ANY TIME.

Additional suggested language for protocols requiring a urine pregnancy test:

If you are a female 12-55 years old, you will be asked to take a urine pregnancy test immediately before your MRI. The person performing the MRI will obtain the results of the pregnancy test before administering the scan. If the test is positive, a scan will not be performed. We will inform you that your test is positive, and you will be advised to contact your personal physician.

*Note – the PI should include a plan for dealing with incidental findings.

References: ACR guidance document on MR safe practices: 2013. Expert Panel on MR Safety. Journal of Magnetic Resonance Imaging, 35:501-530; 2013.
http://www.mrisafety.com/

Attachments: A: MRI Screening Form, B: MRI Scan Tracking Log

Appendices: None

Approver: CTRU Medical Director

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