Annual Ceiling Amount: $

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1 High Field Magnetic Resonance Imaging Center Research MRI Suite, Basement Floor of Building 203 VAMC 4150 Clement Street, San Francisco, CA MR STUDY APPLICATION for Research Users Application date: Return application or direct questions to: Corrina Fonseca (415) x23088 Fax: (415) PRINCIPAL INVESTIGATOR Address: Dept: STUDY Study Title: Proposed start date: Estimated # of scans: Proposed end date: Estimated # of scan hours: Grant Institution: VA NCIRE UCSF Other PO #: PO#: PO #: Bill To: Project #: Dept. ID #: Address: Project #: Unfunded Estimate of Use: hr Potential Funding Source: Estimated Start of Funding: Annual Ceiling Amount: $ CO-INVESTIGATOR(S) Dept: Dept: SCAN TECHNICIAN(S) Who will conduct your scans? (Check one) CIND scan technician I (or members of my team) will scan Dept: Have completed TMS trainings in both MRI Safety and Radiation Safety Require training in MRI scanner use Have been trained in MRI scanner use by Have received MRI safety and emergency training Dept: Have completed TMS trainings in both MRI Safety and Radiation Safety Require training in MRI scanner use page 1 of 10

2 Have been trained in MRI scanner use by Have received MRI safety and emergency training * If more than two techs, attach additional information to end of application MR Study Application AUTHORIZED SCHEDULER(S) STUDY TYPE (check all that apply) SFVAMC 3T SIEMENS SKYRA SFVAMC 7T SIEMENS MAGNETOM Phantom ADNI phantom BIRN (agar) phantom NIST Diffusion phantom Human Approved CHR #: Expires: Normal Volunteers Patients Study Disease: Have you included everything? Check off materials included with your application: ALL STUDIES Detailed Imaging Research Protocol (pages 3-5) Abstract / rationale for the proposed study (page 7) Copy of VA TMS MRI Safety and Radiation Safety Trainings completion certificates for all staff who will utilize the scanner HUMAN STUDIES Copy of CHR Approval Notification** Copy of CHR-Approved VA Informed Consent Copy of CHR-Approved HIPAA Clinical MRI Reads Form (page 6) As PI, I have read and agreed to the CIND High-Field Magnet Resonance Imaging Center Policies (pages 9-10) PI s Name PI s signature Date page 2 of 10

3 ** If you have yet to submit to CHR or are awaiting approval then you may request to do development work under the CHR approved study protocol of Dr. Pratik Mukherjee. Please contact Dr. Mukherjee or Corrina Fonseca for more information. Detailed Imaging Research Protocol We request additional scan time for sequence development hr(s) Estimated # of hours for development work on scanner Development work will include scanning human subjects COIL TYPE - Please selected all applicable **These coils are shared with the VA Department of Radiology and special arrangements will need to be made if you plan to use any of these coils If you plan to use a coil that is listed below, attach showing permission to use coil(s) 3T Skyra Coils: Body 32 Channel Spin Matrix 20 Channel Head/Neck 32 Channel Head 36 Channel Peripheral 16 Channel 4 Channel Large Flex 4 Channel Small Flex Angio Hand/Wrist** 16 Channel Shoulder Large** 16 Channel Shoulder Small** 7T Magnetom Coils: Nova Medical 1 Channel Transmit / 32 Channel Receive Head 15 Channel Transmit/Receive Knee (QED)** MR Research Protocols (Please also attach a copy of entire protocol) For new protocols: Fill-in as much as possible, see last column for example. Space for additional series on page 5. Series Example Sequence MPRAGE Type & Plane Sagittal Voxel Size 1.0x1.0x2.0 mm Imaging Time (min:sec) 5:30 TR 2300 ms TE 2.98 ms TI 1000 ms Flip 9 deg Bandwidth 240 FOV 256 Fat Suppression Water excit. Fast PAT mode GRAPPA Accel. Factor PE 2 Matrix 256x256 Number of Averages 1 Phase Encoding Directions AP b-value n/a Diffusion Directions n/a page 3 of 10

4 # of b0s within Diffusion n/a NOTES: LIST EVERY ITEM THAT WILL BE TAKEN INTO THE MAGNET ROOM: TOTAL SCAN TIME for Research Protocol = (hr:min) TOTAL TIME per SESSION (Includes set-up, removal, image back-up, etc.) = hr (rounded to the nearest ½ hr) IMAGE TRANSFER/ARCHIVAL How will data be transferred off the system: How will data be backed up: ADDITIONAL EQUPIMENT Please select all you intend to use EEG fmri fmri Compatible Glasses Head Cap MR compatible Avotec Audio/Video 32 Channel Cap, Stimulus Capibility BRAIN PRODUCTS Sound Compressor/Amplifier Recording Software, Brain Vision Response Pads, OTEC, and Controller, Cedrus Lumina Application Software, E-Prime Moiré Phase Tracking System for Prospective Motion Correct, Metria Innocation Inc. MPT High-Field Camera and Lighting Unit MPT Motion Tracking Markers** MPT Motion Tracking and Measurement Reporting System **Please note that MPT motion tracking markers fixed to individual month guards will require additional fee. page 4 of 10

5 Series Example Sequence MPRAGE Type & Plane Sagittal Voxel Size 1.0x1.0x2.0 mm Imaging Time (min:sec) 5:30 TR 2300 ms TE 2.98 ms TI 1000 ms Flip 9 deg Bandwidth 240 FOV 256 Fat Suppression Water excit. Fast PAT mode GRAPPA Accel. Factor PE 2 Matrix 256x256 Number of Averages 1 Phase Encoding Direction AP b-value n/a Diffusion Directions n/a # of b0s within Diffusion n/a NOTES: page 5 of 10

6 Clinical MRI Reads Please select an option regarding the post-acquisition evaluation of a patient: STENTOR For participants with a medical record in the SFVA Will all subject scans require reads to be performed? Yes No MR Study Application If no, please provide rationale: Are controls also being recruited? Yes No Other Please identify the group that will be performing the clinical reads for your study: How will images be transferred: None Please list the reason(s) for declining read reports: page 6 of 10

7 Abstract / Study Aims: (Please specify imaging goals by stating the number of subjects, number of scans and number of time points for your study.) page 7 of 10

8 APPROVALS (leave this page blank) MR Study Application CHECKLIST CHR / VA current approval, consent CHR /VA approved investigators Fund / DPA/ PO valid for billing Imaging protocol reviewed, scan time appropriate Radiologist for human subject studies or Waiver Image archival requirements reviewed TMS Certificates Diana Truran Sacrey, Recharge Analyst and Chief Operations Manager - Checklist and funding reviewed and approved Signature Date Corrina Fonseca, 3T Magnet Lead and Imagining Technician - Imaging protocol and procedures reviewed and approved. Signature Date Jacqueline Hayes Project Manager CHR and Consent forms reviewed and approved Signature Date Pratik Mukherjee MD, PhD, CIND Director and Associate Professor, application approved Signature Date Notes: page 8 of 10

9 High Field Magnetic Resonance Imaging Center Policies MR Study Application Investigators who would like to begin scanning on the 3T Skyra must submit an MR Study Application form to the CIND. Applications will be reviewed to determine the priority for scan time allocation. Scanner Usage Standard operating hours are from 8:00 a.m. to 6:00 p.m., Monday through Friday. CIND MRI technologists are available to scan from 9:00 am to 5:00 pm, for an additional fee of $35 per hour. The 3T Skyra scanner is also available after-hours for users who are cleared to conduct MR examinations on their own. CIND staff may be available to assist with after-hour scans if advance notice is requested, preferably two weeks prior to the scan. Please contact Lillian Chiu at to schedule CIND staff. For access to the MRI suite, contact Lillian Chiu. A single key to the MRI suite will be issued to the study PI. Scan technicians are responsible for logging both development and funded scanner usage in the billing database. CIND staff will assist with billing database setup and logging training. The entry will be linked to the study PO number for easy billing once scanning is ready to begin. Periodically the 3T Skyra will be unavailable for use due to planned and unplanned Siemens maintenance. Scheduled Siemens preventative maintenance will be marked on the 3T MRI calendar with advance notice. Unscheduled Siemen service resulting for system errors and/or faulty equipment will be communicated to users with as much notice as is possible. If necessary, previously scheduled research scans may have to be cancelled to accommodate unplanned Siemens service. In addition, the SFVAMC Department of Radiology occasionally uses the research 3T Skyra scanner for patients; please see the online 3T MRI calendar for a list of dates and times when the MRI scanner is unavailable to research users. Scheduling Magnet Time Please use the online scheduling system to reserve time on the 3T Skyra scanner. Contact Lillian Chiu, Lillian.Chiu@va.gov, to request creation of website log-in information. The website login is: MRI users may schedule scans during the open MRI slots. Unlike assigned MRI appointment slots, open magnet slots may be utilized by ALL users. Recurring MRI appointment slots are assigned to funded studies and are determined based on the study s recruitment totals. For example, if study goals are to acquire 50 scans within one year, then a weekly slot is allocated to achieve recruitment goals. Additionally, we factor in the length of the MRI scan protocol as well as time required to prepare for the scan, including consenting of the research participant, MRI Pre- Screen, and EEG cap set-up. Skyra users do not own their slots. If one week prior to a scheduled slot, the MRI appointment has yet to be scheduled, then this time becomes available to ALL Skyra users on a first-come, first-served basis. We call this is our One Week Rule. Projects are only billed for the time when the Skyra is actually used, which is why we require all users log the total time spent using the MRI scanner and study information in the Magnet Billing database. For more information please see MRI Scheduling Guidelines. page 9 of 10

10 Development and Training ALL individuals scanned at the 3T Skyra, even those volunteering for development or trainings, MUST complete the appropriate pre-screen form and informed consent paperwork before their scan. Persons obtaining consent from research participants must be listed on the CHR/IRB approved study protocol. Please verify that you are on the study protocol before obtaining consent. For questions with this please contact Jacqueline Hayes, All individuals who will be utilizing the MRI must receive magnet safety and emergency training from CIND staff prior to their first scan. They must also provide copies of certificates of TMS trainings in MRI safety and radiation safety. Users should be fully trained in use of the Skyra system or request training prior to use. If you have yet to submit to CHR or are awaiting approval, you may request to do development work under the CHR approved study protocol of Dr. Pratik Mukherjee. Please contact Dr. Mukherjee or Corrina Fonseca for more information All scheduled MRI trainings or protocol development may be bumped for research scans with participants. If you are taking one of these slots for your study s subject scan, you must notify the owner of the appointment you are bumping with as much notice is possible. Metal Safety CIND policy is to not scan any subjects with undocumented or unconfirmed metal implants. Recruiters and schedulers are responsible for screening their subjects for metal safety and for researching implants they learn about before scheduling a scan. They must communicate the manufacturer and model name/number of the implant to CIND staff and wait for clearance; only after clearance is obtained may the MRI examination be scheduled. Relay all notes about the implant(s) to CIND staff. If metal safety information is not researched or communicated to CIND in advance, the scan will be delayed or cancelled until MRI safety is confirmed. Facilities Resources CIND will provide the following items which can be utilized by all users: earplugs, MR-spots, ear covers for system headphones, sanitation wipes. CIND will also stock linens supplies (sheets, pillow cases, blankets). It is the responsibility of each user to prepare the 3T MRI suite for the next group; this includes removing used linens, disposing of used linens in the linens bin/chute, disinfecting the patient table, head coil, and headphones, returning all equipment (i.e., pulse monitor), phantoms, and coils to their designated areas, and tidying up the console room. If we are running low on supplies please notify Lillian Chiu. In order to maintain the integrity of the software system, CIND reserves the right to delete images/data from the 3T Syngo system at any time. It is imperative that users export and/or archive data immediately after the time of acquisition, and to also delete from temporary storage locations. MR High Field Imaging Recharge Rates SFVAMC 3T Siemens Skyra Cost MR Scan / hr (billed in 15 min intervals) MR Technologist (billed in 1 hr intervals) Consultation / hour page 10 of 10