MS GA 301 MRI Training

Transcription

1 MS GA 301 MRI Training Jennifer L. Cox, Ph.D. Director, Translational Research Unit Buffalo Neuroimaging Analysis Center Research Assistant Professor of Neurology State University of New York at Buffalo

2 Presentation Overview Why MRI MRI Requirements Set up Dummy Run Example Images Study Exams Data Transfer

3 MS GA 301: The GALA Study Secondary Outcome Measures The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. The cumulative number of enhancing lesions on T1 weighted images taken at months 6 and 12 (end of PC phase). Brain atrophy as defined by the percent brain volume change from baseline to month 12 (end of PC phase).

4 MRI Exam Visits Per protocol MRI Exam visits: Baseline Visit (month 0) MRI acquired 7 13 days prior to Baseline Visit Month 6 Month 12

5 Required Sequences Dual Echo T2 weighted image (WI) (PD/T2) 3D T1 WI high resolution image (IRFSPGR/MPRAGE/IR TFE) Fluid Attenuated Inversion Recovery (FLAIR) Spin Echo (SE) T1 WI Spin Echo (SE) T1 WI with gadolinium (Gd) contrast

6 Training and Resources MRI Technologist Manual Teleconference BNAC will schedule a pre dummy run teleconference with every site. Additional teleconferences will be scheduled as needed to answer questions BNAC Website: Password protected Download study documents, forms Sample images BNAC Help Line

7 MRI Technologist Manual Provided to sites in electronic format (pdf) Step by Step guide Contains specific instructions for obtaining correct sequences/images all relevant logistics Contains instructions for dummy and routine study scan Please read

8 Dummy Run Parameters Tables GE, Philips, Siemens 1.5 & 3T tables provided to be used as a starting point

9 Key to Dummy Run Success You know your scanner the best, please provide the best scans possible within the voxel size specified in the tables.

10 Key to MRI Research Success: CONSISTENCY!!

11 Requirements Use 1.5 Tesla scanner wherever possible 1T and 3T allowed Use same (approved) scanner for all study subjects for all visits Use the same contrast agent for all exams Use ½dose of Multihance Retain local archive copy of all scans Save approved scan parameters into scanner console

12 Communication BNAC SITE Local MRI Facility MRI Coordinators are responsible to ensure the MRI is collected and shipped to BNAC. Establish good communication between Study Coordinator, MRI Facility, and BNAC Needed for subject scheduling (Prospective Scan Schedule) Transfer of subject demographics and weight (SC to use MRI Exam Order Form) Completion of MRI documentation by MRI Technologists, Radiologists, and Coordinators Exam transfer to BNAC by MRI Coordinators

13 MRI Process Overview 1. Study Set up Site Questionnaire Data Transfer: SFTP or courier Training 1. MRI Technologist Manual 2. Pre dummy run teleconference for every site 2. Dummy Run Exam Evaluation Site Certification & Approved Scan Parameters Site specific Study Exam Order Forms 3. Study Exams Exam Evaluation Projected Scan Schedule

14 MRI Process: Start up

15 MRI Process: Start up

16 MRI Process: Start up

17 MRI Process: Start up Courier Kit Contents: Instructions Airway bills CD Labels Proforma Invoice (International Sites)

18 MRI Process: Start up SFTP: 1. Receive instructions 2. Send test to BNAC

19 MRI Process: Start up Pre-Dummy Run Telecon Agenda 1. Introductions & Roles 2. Dummy Run Basics 1. Subject: MS pt preferred, or control 2. No contrast 3. Blind patient identifiers 4. Parameters 5. Filters 3. Forms 4. File transfer confirm CD/SFTP & supplies 5. Expected Dummy Run date? 6. Other issues or concerns

20 Next Step, Dummy Run Exam IMPORTANT No site can perform the dummy run until all necessary regulatory, ethics and contractual approvals have been received at the site

21 Next Step: Dummy Run Exam Next step after Questionnaire Instructions in MRI Technologist Manual MS patient or healthy control Subject must give Informed Consent via approved ICF Use Dummy MRI Exam Order Form Scans (DICOM standard) sent to BNAC via SFTP or CD MRI Transmittal/Receipt Information completed and ed or faxed before transferring/shipping

22 Dummy Run: Timeline Overview CRA notifies BNAC that Site is ready for Dummy Run BNAC contacts Site to set up Pre Dummy Run telecon, to occur within 5 business days prior to Dummy Run. Pre Dummy Run Telecon: MRI Technologist/Radiologist, Study Coordinator, CRA attend Site acquires Dummy Run within 5 days after telecon with BNAC Site ships exam (SFTP/CD) to BNAC within 1 business day. BNAC notifies Site of receipt of exam (when exam arrives) BNAC communicates the rejection/acceptance of the exam to the sites within 3 business days of scan receipt at BNAC. If required, Site repeats sequences as soon as possible, within 14 days.

23 MRI Process: Dummy Run

24 MRI Process: Dummy Run

25 MRI Process: Dummy Run Completed by SC

26 MRI Process: Dummy Run Subcallosal Plane

27 MRI Process: Dummy Run Completed by Radiologist

28 MRI Process: Dummy Run Completed by BNAC

29 MRI Process: Dummy Run

30 Key to Dummy Run Success You know your scanner the best, please provide the best scans possible within the voxel size specified in the tables.

31 Example of passed images PD T2 T1 FLAIR

32 Example of failed images FLAIR T1 PD

33 3D T1 Inversion Recovery Spoiled Gradient Echo Failed Passed

34 Guy Poloni s Tips for Dummy Run Success 1. For each sequence, start from the equivalent set on the scanner and used for everyday clinical activity 2. Geometry is the only part of the table which must be matched identically. some older scanners might forbid matching some parameters (for example some older software versions would only accept integer values for the FoV), in this case the closest value possible should be chosen and the limit should be pointed out when sending the Dummy Run

35 Guy Poloni s Tips for Dummy Run Success 3. Your experience on the scanner may hold more than the suggested parameters (guide). That is: every scanner is born different and the same parameters won't give identical results in different sites. Before changing any of the acquisition parameters, have an overall look at the settings: if all of them are close, do not change. The table we send is a guideline, but will not substitute the fine tuning that every sites goes through. If major differences are observed between the suggested parameters and the scans in use for clinical purposes, please feel free to contact us for advice.

36 Guy Poloni s Tips for Dummy Run Success 4. In order to let us correctly evaluate the scan quality, identify a motivated and cooperative volunteer for the dummy run scan, in order to avoid quality evaluation problems as a consequence of movement artifacts.

37 Guy Poloni s Tips for Dummy Run Success 5. When any scan is done during the dummy run, please keep in mind the image quality you are used to during the everyday activity. If the scan turns out to be much worse, then try to go back to the scanning parameters you use clinically. Again only geometry should be matched identically.

38 Guy Poloni s Tips for Dummy Run Success 6. Definitions change from scanner to scanner, the baseline is the following: PD/T2 has a saturation pulse and an inferior saturation band T1 SE has no saturation band, but based on the experience of the site an inferior saturation band might be considered useful FLAIR only has an inferior saturation band and no saturation pulse.

39 Key to Dummy Run Success You know your scanner the best, please provide the best scans possible within the voxel size specified in the tables.

40 MRI Process: Dummy Run START

41 Dummy Run Approval IMPORTANT No site can commence scanning subjects in the study until Dummy Run exam is approved

42 Study Exam: Timeline Overview Site to transfer/ship exam to BNAC within 24 hours after the exam. 7 days courier time allowed for study scan arrival in BNAC BNAC will communicate the acceptance or rejection of the exam to the sites within 1 business day of exam receipt at BNAC If any scan needs to be repeated, sites are asked to acquire the scan within 3 business days.

43 MRI Process: Study Exams

44 MRI Process: Study Exams Completed by SC

45 MRI Process: Study Exams

46 MRI Process: Study Exams

47 MRI Process: Study Exams

48 MRI Process: Study Exams

49 Projected Scan Schedule After baseline visit, BNAC will work with SC to complete expected visit dates BNAC uses as reminder when to expect next exam

50 Queries MRI Database Query form will be issued for any questions about MRI data Queries need to be addressed and closed within 3 business days

51 Scanner Update Sites need to inform BNAC of any changes that could affect MRI data: MRI scanner Head coil Software

52 Scan Transfer to BNAC The preferred method for scan transfer to BNAC is electronically via SFTP If you are unsure whether this is possible for your site, please contact your I.T. Department If site is unable to transfer scan images electronically by SFTP, use courier (FedEx, DHL)

53 Shipment Timings MRI Exams should be sent real time and no later than 24 hours after scanning Do not batch for longer periods One subject exam per CD

54 Scan Shipping Make two archive copies of scan data (one to CD) Download to CD in DICOM Standard Send to BNAC using courier supplies sent at study start up Send MRI Order Form with transmittal information via fax/e mail before shipping Include copy of Exam Order Form in the shipment

55 Shipping Instructions: Overview 1. Place labeled CD in envelope 2. Sign and date appropriate pre printed airway bill DO NOT TICK ANY BOXES ON THE AIRWAY BILL 3. Complete Proforma Invoice if shipping to BNAC from outside the USA. 5 copies with original signature/date 4. Call courier for pick up

56 CD Label Provided in Courier Kit Complete and attach to CD case for all MRI exams

57 SHIPPING Label the CD with a waterproof marker or professional CD labelling system on the upper side Do not put labels directly onto the CD or label on the underside

58 Shipping: FedEx Pre printed airway bill Insert full name (first and last) Note the tracking number in the transmittal information area on the MRI Order Form Site Address #, Weight & Value $1.

59 Shipping: DHL Sign and date airway bill, and note the tracking number in the transmittal information area on the MRI Order Form DO NOT TICK ANY BOXES!

60 Shipping: DHL Proforma Invoice International Shipments Only Complete the Proforma Invoice according to the instructions provided in courier kit at start of study

61 CONTACT DETAILS BNAC Cheryl Kennedy, Clinical Trial Manager Buffalo Neuroimaging Analysis Center The Jacobs Neurological Institute 100 High St. Buffalo, NY USA Tel: E mail: MSGA301@bnac.net BNAC Help Line:

62 Thank You for Your Attention

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