WHIMS/ACCORD and MIRC

• Multi-institutional MR Studies of Cerebrovascular Disease– Protocol development– Data acquisition QC– Data archival

• Data distribution– Data analysis

Action to Control Cardiovascular Risk in DiabetesAction to Control Cardiovascular Risk in Diabetes

ACCORD-MINDACCORD-MIND

MMemory emory inin DDiabetesiabetes

September, 2004

Lenore J. LaunerLaboratory of Epidemiology, Demography, Biometry,

National Institute on Aging

Diabetes and AD

1.4 1.9

Rochester, MinnHawaii AD w/ CVD

3.0

AD w/ CVD

1.3 3.4

1.9

N. Manhattan, NY AD Dementia with strokeRotterdam, NL AD

RR

Ott et al., 1999; Leibson et al., 1997, Luchsinger, 2001, Peila, 2001

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.

Women’s Health Initiative Memory Study (WHIMS)

Effects of Hormone Therapy on Subclinical Neurological Pathology

(WHIMS-MRI)

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

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

MRI PROTOCOL- ACR QC TEST

• Gradient Uniformity• Low Contrast Detectability• High Contrast Spatial

Resolution• Slice Thickness• Signal-Noise (SNR)• Ghosting Artifacts

WHIMS MRI PROTOCOL

• 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.

PULSE SEQUENCES

WHIMS MRI PROTOCOL

Sag localizer Ax Vol T1 SPGR Ax FLAIR

Ax PD Ax T2

FCDICOM

HTTP / HTTPSFCDICOM

FCDICOM

PIDICOM

PIDICOM

MIRC Clinical Trial Configuration

WHIMS MRI Study

• Data Analysis– Tissue segmentation– Spatial normalization

• ROI labeling– Structure/Function Correlation

• ROI based• Voxel based

Data Analysis Flow Chart

T1 image VolumeSkull Stripping Tissue Classification

Model based ROI Labeling (HAMMER)

ModelLabeled andMeasured

ROI’s

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.

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

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)

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

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

WHIMS-MRI Field Centers

•UNC-Chapel Hill•Columbus•Milwaukee•Minneapolis•New York•Pittsburgh•Penn- MRIQCC

• Davis• Des Moines• Gainesville• Los Angeles• Nevada• Stanford• Worcester

MIRC Image Transmission ProgressMIRC 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

MIRC Image TransmissionMIRC 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

Image Transmission using MIRCImage 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.