WHIMS/ACCORD and MIRC

1. WHIMS/ACCORD and MIRC • Multi-institutional MR Studies of Cerebrovascular Disease • Protocol development • Data acquisition QC • Data archival • Data distribution • Data analysis

2. Lenore J. Launer Laboratory of Epidemiology, Demography, Biometry, National Institute on Aging Action to Control Cardiovascular Risk in DiabetesACCORD-MINDMemory inDiabetes September, 2004

3. RR N. Manhattan, NY AD Dementia with stroke Rotterdam, NL AD 1.3 3.4 1.9 AD w/ CVD 3.0 Rochester, Minn Hawaii AD w/ CVD 1.4 1.9 Diabetes and AD Ott et al., 1999; Leibson et al., 1997, Luchsinger, 2001, Peila, 2001

4. ACCORD-MIND • 640 SUBJECTS WILL PARTICIPANT IN THE MRI COMPONENT • THE SUBJECTS WILL BE RECRUITED FROM 3 FIELD CENTERS • COLUMBIA • WAKE FOREST • UNIVERSITY OF MINNESOTA • CASE WESTERN RESERVE* • MRI’S WILL BE PERFORMED AT • Baseline period upon enrollment • 48-month follow-up.

5. Women’s Health Initiative Memory Study (WHIMS) Effects of Hormone Therapy on Subclinical Neurological Pathology (WHIMS-MRI)

6. WHIMS-MRI Study • Primary Goal • Conduct a cross-sectional MRI substudy on approximately 1,450 women from the WHIMS E+P and E-only trials to document the relative rate of subclinical infarcts associated with E+P and E-only therapy

7. WHIMS MRI PROCEDURE • STANDARDIZED ACQUISITION • FULL BRAIN COVERAGE • 1.5 or 3MM SLICE THICK/NO GAP • SLICE ANGLE AND POSITION ALONG AC/PC • ON SITE DATA ARCHIVE • DATA TRANSMISSION TO MRQC CENTER • Quarterly ACR TEST/SCANNER QC

8. MRI PROTOCOL- ACR QC TEST • Gradient Uniformity • Low Contrast Detectability • High Contrast Spatial Resolution • Slice Thickness • Signal-Noise (SNR) • Ghosting Artifacts

9. WHIMS MRI PROTOCOL PULSE SEQUENCES • Series 1 – 3 plane Gradient echo localizer for positioning. • Series 2 – Sag T1 mid-slice image to demonstrate anatomical location of the AC/PC for slice angle and position. • Series 3- Oblique Axial Spin Density/ T2-weighted from the vertex to skull base parallel to the AC/PC plane. • Series 4 - Oblique Axial FLAIR T2- weighted images matching slice positions in Series 3. • Series 5 - Oblique Axial 3D SPGR T1 weighted-images matching slice positions in Series 3.

10. Sag localizer Ax Vol T1 SPGR Ax FLAIR Ax PD Ax T2 WHIMS MRI PROTOCOL

11. DICOM FC DICOM PI DICOM FC DICOM PI DICOM FC MIRC Clinical Trial Configuration HTTP / HTTPS

12. WHIMS MRI Study • Data Analysis • Tissue segmentation • Spatial normalization • ROI labeling • Structure/Function Correlation • ROI based • Voxel based

13. Data Analysis Flow Chart Tissue Classification Skull Stripping T1 image Volume Model Labeled and Measured ROI’s Model based ROI Labeling (HAMMER)

14. WHIMS MIRC • Enter WHIMS patient and study info at MR scanner. • Send images to your local MIRC site as if it were a PACS. • The MIRC site will forward the images to the principal investigator site(s) automatically.

15. Image Transmission Current Methods • Network based medical image transmission • MIRC • ACRIN • Ftp • Physical archival/storage media transmission • CD-ROM (Raw format/Dicom CD) • DAT tape (Raw format/Dicom) • MOD • Radiographic Films

16. Image Transmission from Imaging Facilities to MRI Analysis Centers • Problems with standard File Transmission Protocol (FTP) • Security! No encryption, not HIPAA-compatible • Blocked by enterprise firewall • No imaging data property preservation (time, owner, etc.) • Problems with other image data methods (CD-ROM, DAT, MOD, Films) • Incorrect and/or missing data • Unreadable format • Transferring data ( lost shipping and delays) • Damaged archived media • Filmless institutions/Film is expensive • Un-anonymized data sent (HIPAA requirements)

17. MIRC Image Transmission/Retrievalfrom FC to Reading Center • Clinical Trial Personnel • MRI Reading Center • PI, Coordinator, IT support • MRI Field Center • IT support/Service engineer • MRI technologist • Radiologist

18. WHIMS-MRI RECRUITMENT(CROSS-SECTIONAL STUDY) • 1450 SUBJECTS WILL PARTICIPATE IN THE MRI COMPONENT (3 YEAR PERIOD) • THE SUBJECTS WILL BE RECRUITED FROM 14 WHI PARTICIPATING CLINICS

19. Davis Des Moines Gainesville Los Angeles Nevada Stanford Worcester WHIMS-MRI Field Centers • UNC-Chapel Hill • Columbus • Milwaukee • Minneapolis • New York • Pittsburgh • Penn- MRIQCC

20. MIRC Image Transmission Progress • Since the initial start-up ( 09/04) of the WHIMS trial: • All 14 FC have been contacted to verify a timeframe for MIRC installation • 6 FC completed with installation and transfer • 8 FC pending transmission • 2 FC approved for recruitment • 1 FC recruitment begins 12/1/04 • Completion of all FC for MIRC installation and recruitment anticipated by 12/31/04

21. MIRC Image Transmission • Installation delays- WHIMS-MRI Field Centers • IT Personnel timeframe • FC Network/Firewall/Proxy Server issues (varies between sites) • 1 FC : 1hour installation • 1 FC : 2 days (proxy server issue) • 4 FC : 3 days-1 week ( Network permission and protection) • Transmission/retrieval issues at MR reading center (Penn) • 1 FC : successful transmission of imaging data (approx. time 5 minutes from FC to MRQC) • 1 FC : dicom elements re-identification • Firewall issues at MR reading center (Network permission) • 2 weeks for access to port and identify problems/issues

22. Image Transmission using MIRC • Advantages: • Automatic network-aware transmission/resending using standard Secure Internet Protocol (HTTPS). • User-friendly, requires minimal interference once installed at FC. • Reduction in delays for sending and receiving of MRI image data • Improved tracking methods/organization of data • Disadvantages: • Time consuming for multi-center trials: Initial set-up , ongoing communication and installation of individual FC sites. • Improvements: IT support and/or Network issues are identified at each site prior to training session and installation time period. • IT support for clinical research trials that specifically involve the collection of imaging data among mulitple sites.