Monthly Webinar Series February, 2019
Today’s Agenda Announcements/Trial Updates Christina Grabarits Mt. Everest & Rowing Competition Christina Grabarits Top Enroller Christina Grabarits 11 Points for MRI Success Blake Dewey Recruitment Tips and Trends Karen Lane Q&A All
Announcements/Trial Updates CHRISTINA GRABARITS
TREAT-MS Trial Study Updates We now have 34 sites activated and 82 patients enrolled!! 6 more sites have IRB approval! Congratulations to three sites for enrolling 2 patients each in January: Mayo Clinic Swedish Health Services University of Washington Let’s make a big push to enroll 1 patient each week this month! Please reach out for anything we can do to help you!
Bi-weekly Enrollment Newsletters! Every 2 weeks sites will be sent enrollment newsletters, breaking down the screening & enrollment progress per site per month. These are a great way to see how your rowing team is doing & how close you are to passing the team ahead of you!
Monthly Bulletins! Be on the lookout for the Monthly Bulletins from the Johns Hopkins CCC These Bulletins are full of important trial information & fun facts too! Bulletins are sent our the 3 rd week of each month. Print & post copies around your office or break room & be sure to share copies with your team!
Next in-person Study Advisory Committee (SAC) meeting will be held in Dallas, TX on Save the Date!!! February 27, 2019 from 1:30 – 5 pm, preceding the ACTRIMS meeting.
The Mount Everest Climb CHRISTINA GRABARITS
ELEVATION Mount Everest Contenders Activated Sites 65.6 1. RWJ Barnabas Multiple Sclerosis Comprehensive Care Center 2. Georgetown University 40.5 36.4 3. Rush University Medical Center 32.5 4. University of Massachusetts Worcester 31.1 5. Oklahoma Medical Research Foundation 30.4 6. Hackensack University Medical Center 27.7 7. Icahn School of Medicine 25.5 8. University of California Los Angeles 23.7 9. Geisinger Clinic 10. University of Michigan 23.5 *Not fit to scale
Activated Sites 1. Johns Hopkins University 18. University of Louisville 2. Christiana Care 19. Baylor Scott & White Health 3. Advanced Neurology Specialists 20. University of Cincinnati 4. University of Vermont 21. University of Washington 5. New York University School of Medicine 22. Central Texas Neurology Consultants 6. University of Florida Gainesville 23. University of Miami 7. Swedish Medical Center 24. Ohio Health 8. Norton Neurology Services 25. University of Utah 9. University of Alabama at Birmingham 26. University of Maryland 10. University of Rochester 27. Neurology Specialists of Tidewater 11. University of California at San Francisco 28. Dignity Health Sacramento 12. University of Kansas Medical Center 29. Providence Health 13. Columbia Presbyterian 30. Allegheny Health Network 14. Mayo Clinic 31. Billings Clinic 15. University of South Florida Health 32. Massachusetts General Hospital 16. Stony Brook University 33. Cedars Sinai 17. Vanderbilt University Medical Center 34. University of California San Diego
Mount Everest Standings Rank Activated Sites Final Points 1 Christiana Care 134.5 2 Norton Neurology Specialists 130.9 3 Baylor Scott & White Health 120.3 4 Columbia Presbyterian 112.6 5 Central Texas Neurology Consultants 104.1 6 University of Cincinnati 102.5 7 Dignity Health Sacramento 93.0 8 Allegheny Health Network 91.5 9 University of California San Diego 89.1 10 Advanced Neurology Specialists 85.3
The Rowing Competition CHRISTINA GRABARITS
Rowing Competition Standings West Team A West Team B Advanced U of Washington UCSF U of Utah Swedish Neuro Spc Northeast Team G Dignity Health UCSD Providence Cedars Sinai Billings Clinic U of Rochester Stony Brook NYU Midwest Team C South Team E Mayo Clinic Ohio Health U Cinn CentralTx U of U of South Miami Florida Health Neuro U of Louisville Norton UFL Gainesville JHU Northeast Team H U Vermont Columbia Presby South Team F Mass Gen Allegheny Health UAB U of Maryland Midwest Team D Neuro Spc of Vanderbilt Christiana Care Tidewater Baylor Scott & KUMC White Health
Rowing Competition Standings Site Points 1. Advanced Neurology Spc 65 2. Norton 60 Individual Site 3. UFL Gainesville 58 4. Swedish 52 Competition 5. Christiana Care/ UAB 45 6. U Kansas Med Ctr 37 7. NYU/ U of Washington 36 8. Allegheny Health Network 26 9. USouth FL Health 20 10. Mayo Clinic 19
Rowing Competition https://treat.preludedynamics.com
Activated Sites *AS OF FRIDAY, 02/01/19
Recent Enrollments *AS OF FRIDAY, 02/01/19
Monthly Randomization Race January Top Performers: Site Randomizations Johns Hopkins University 4 Swedish Medical Center 2 Mayo Clinic 2 University of Washington 2 Total in January 18
January’s Top Enrollers: Swedish Medical Center Mayo Clinic University of Washington $50
TREAT-MS: 11 Points for MRI Success Blake Dewey TREAT-MS Image Analysis Group Johns Hopkins University
#1: Imaging Overview • Standard of Care! • Billed to Insurance • As few changes as possible • High quality imaging • For you and your patients! • A powerful tool for MS observation • And for research! 41
#2: MRI Manual (v6) • Read through the MRI Manual (v6) • On treat-mstrial.org • Minor changes to file naming in Vision Upload • Clarification about Scan Record Email • Ask any and all questions! • Email us at treatmsimaging@jhmi.edu • Send the manual to your MRI team • Remember to include our email address! 42
#3: Imaging Priorities 1. Consistency, consistency, consistency! • Same scanner as 6 month scan 2. 3T Scanner 3. Follow the MRI Guidelines • Section 4 of the MRI Manual Communicate Early and Often! We are here to help you get great images! treatmsimaging@jhmi.edu 43
#4: Imaging Timeline • Baseline Month 48 • Doesn’t have to be at TREAT -MS site • PLEASE SEND IT ANYWAY!! Month 36 • Month 6 • After 6-8 months on DMT!! Month 24 • Looking for breakthrough activity • Our true “baseline” Month 12 • Yearly follow-ups (12, 24, 36, 48 months) Month 6 • Continued follow- up… Begin DMT Baseline 44
#5: Re-baseline • Not the “Month 6” Scan • Ordering an additional baseline scan for comparability • Possible reasons to order a re-baseline: 1. Too old (possible activity before DMT) 2. Poor quality (difficult to compare to Month 6) 3. Incomplete (hard to compare/risk stratify) • Better evaluation after DMT starts • Good way to get “First Patient Option” scan (#8) 45
#6: Month 6 Scan • Most critical scan to have (and time correctly) • Can switch therapy for ANY NEW breakthrough disease AFTER 6 mos. • Incorrect timing reduces support for claim of breakthrough disease • Timing • ≤ 6 months: only able to confirm new lesion after 6 mos. if enhancing • 6-8 months: can confirm new lesions by comparing to baseline • > 8 months: enhancing lesions must have occurred after 6 mos. • New lesions (non-enhancing) can also be compared • Advice: If the patient controls scheduling, don’t order until after 6 mos. on therapy 46
#7: Dummy Scan • Not every site will perform a dummy scan • Healthy control or MS patient • Gadolinium only if clinically indicated • Still run any post gad scans! • Upload to Dummy MRI form for your Site • Send an email to treatmsimaging@jhmi.edu to receive feedback 47
#8: The First Patient Option • Must be completed before first “Month 6” scan • Allows for evaluation and feedback before “true baseline” Checklist: 1. Email Imaging Group (treatmsimaging@jhmi.edu) that you will be using first patient option, including: • MRI Contact Information • Print-out from scanner showing protocol (ask MRI team, if unsure) • JH Imaging will return any requested changes 2. Include “Dummy Run” in the Scan Record Email for the patient to flag for QA 48
#9: Vision Uploads • Upload the entire scan! • Images, not radiological reports • Zip the whole folder • Naming convention XXXX-YYY-ZZ.zip • XXXX – Site ID • YYY – Patient ID • ZZ – Baseline ID (00 for baseline, 06 for Month 6, …) 49
#10: Scan Record Email • Every time a scan is uploaded • Template in Appendix D of MRI Manual To: treatmsimaging@jhmi.edu From: email@example.com Subject: TREAT-MS Scan Upload Receipt – Scan 0100-010-00 Patient ID: 0100-010 Timepoint: Baseline Date of Scan: 8/1/2018 Imaging Center: Johns Hopkins Outpatient Center Comments: No comments Upload Completed By: Blake Dewey Telephone Number: (301) 555-5346 50
#11: Quality - Grey/White Matter (T 1 ) • Looking for structural abnormalities • Masses, deformations, etc. • Qualitative • Differences in tissue sizes • Needs GM/WM contrast • Quantitative • Requires additional processing • Atrophy is an important 2D Spin-Echo T 1 3D MPRAGE biomarker for MS 51
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