1 ACRIN Imaging Core Laboratory

Aim 1 To ensure uniformity and high quality of test performance, image acquisition and image interpretation throughout the trialAim 1: To ensure uniformity and high quality of test performance, image acquisition and image interpretation throughout the trial Aim 2: To develop/deploy technical systems for test transmission and archiving, including creation of a unique data resource for ancillary studies by combining diagnostic tests and clinical dataAim 2: To develop/deploy technical systems for test transmission and archiving, including creation of a unique data resource for ancillary studies by combining diagnostic tests and clinical data 2

3 TRIAD Installation & TRIAD Installation & Sample Data Transfer

TRIAD TRIAD is the American College of Radiology Imaging Network’s (ACRIN) image acquisition and management software. In brief, TRIAD-OA offers a web-based software solution which allows sites participating in the RESCUE trial a secure method to review and submit clinical trial images. For a more detailed explanation of the capabilities and benefits of TRIAD, you may visit the TRIAD learning center at:

TRIAD REGISTRATION and DEPLOYMENT

TRIAD DEPLOYMENT Identify the following key individuals at your site: TRIAD user – the individual(s) who will use TRIAD regularly IT contact – the individual(s) who will assist with the basic installation and testing of the TRIAD software PACS administrator (if necessary) – the individual(s) who will assist with transporting case images from the scanner/PACS system to TRIAD Register for a TRIAD account – this may be done by clicking on the following link: Determine the computer(s) which you would like TRIAD installed on (this machine does not need to be used solely for TRIAD) Determine a time and date that would work best to schedule the TRIAD installation

Prior to a TRIAD installation please register for a username & to a TRIAD installation please register for a username & serAccount/Register.aspx serAccount/Register.aspx

TRIAD INSTALLATION If you feel your site is ready to proceed with the TRIAD installation, please submit an to TRIAD- Include the following information with your 1) date and time you would like the installation to take place, 2) individuals who plan to participate in the installation, 3) site name and number and 4) contact information.TRIAD-

TRIAD: TRansfer of Image and Archive DataTRIAD: TRansfer of Image and Archive Data TRIAD setup is customizable with two (2) basic options for submission of images originating from, or routed through, the Clinical SiteTRIAD setup is customizable with two (2) basic options for submission of images originating from, or routed through, the Clinical Site 9 Selecting TRIAD Options

TRIAD Client Installation of TRIAD client application onlyInstallation of TRIAD client application only For submission of images directly from CD orFor submission of images directly from CD or folders Recommended for low volume sites - Fewer than five (5) CCTA submissions/monthRecommended for low volume sites - Fewer than five (5) CCTA submissions/month

TRIAD Site Server Installation of TRIAD client application and TRIAD site serverInstallation of TRIAD client application and TRIAD site server For submission of images transferred directly from a site’s PACS or Scanner on the same local area networkFor submission of images transferred directly from a site’s PACS or Scanner on the same local area network Recommended for high volume sites - five (5) or more CTA submissions/monthRecommended for high volume sites - five (5) or more CTA submissions/month

TRIAD Client Hardware and Network Requirements: Model: PCModel: PC Processor: Intel P-IV 3 GHz minimum, Intel Core 2 Duo 2GHz is recommendedProcessor: Intel P-IV 3 GHz minimum, Intel Core 2 Duo 2GHz is recommended RAM: 1GB is minimum, 4GB is recommendedRAM: 1GB is minimum, 4GB is recommended HDD: 200Mb for Rich GUI client application itself up to 200Gb- for local image cache, its size will depend on amount of images stored by the systemHDD: 200Mb for Rich GUI client application itself up to 200Gb- for local image cache, its size will depend on amount of images stored by the system Video: Graphic adapter and Monitor with True Color mode support 1024 x 768 pixels x 32 bit color modeVideo: Graphic adapter and Monitor with True Color mode support 1024 x 768 pixels x 32 bit color mode Supported Operating systems and Software Requirements: Workstation running Rich GUI client must be: MS Windows XP SP3, MS Windows 7, MS.NET Framework 3.5Supported Operating systems and Software Requirements: Workstation running Rich GUI client must be: MS Windows XP SP3, MS Windows 7, MS.NET Framework 3.5 Network Requirements: Internet connection- minimum Client connection speed should be at least 256 kbps. Desired connection speed is 1 Mbps.Network Requirements: Internet connection- minimum Client connection speed should be at least 256 kbps. Desired connection speed is 1 Mbps. 12

TRIAD Site Server Supported Operating Systems and Software Site Server Supported Operating Systems and Software Requirements: Requirements: Windows XP SP3, Windows 7 and Windows Server 2003 SP2Windows XP SP3, Windows 7 and Windows Server 2003 SP2 Microsoft.NET Framework 3.5,SQL Express 2005Microsoft.NET Framework 3.5,SQL Express 2005 HARDWARE REQUIREMENTS Model: PCModel: PC Processor: Intel P-IV 3GHz minimum, Intel Core 2 Duo 2GHz is recommendedProcessor: Intel P-IV 3GHz minimum, Intel Core 2 Duo 2GHz is recommended RAM: 1GB minimum, 4GB is recommendedRAM: 1GB minimum, 4GB is recommended HDD: Its size depends on amount of images received from Scanner before they are sent to TRIAD Image Storage.100 Gb minimum, 200Gb is recommended.HDD: Its size depends on amount of images received from Scanner before they are sent to TRIAD Image Storage.100 Gb minimum, 200Gb is recommended.

TRIAD Letter & Consultation Call

TRIAD Greeting Letter is sent (via ) to Site Study CoordinatorTRIAD Greeting Letter is sent (via ) to Site Study Coordinator Prepares your organization by providing requirements for an installationPrepares your organization by providing requirements for an installation ACRIN holds site consultation call with each siteACRIN holds site consultation call with each site Site Study Coordinator should be prepared to confirm the following information:Site Study Coordinator should be prepared to confirm the following information: Installation plan/process for image transferInstallation plan/process for image transfer Number of TRIAD installs requiredNumber of TRIAD installs required TRIAD Installation occurs on scheduled date/timeTRIAD Installation occurs on scheduled date/time Site will be required to submit a test exam during installation to confirm successful TRIAD deploymentSite will be required to submit a test exam during installation to confirm successful TRIAD deployment 15

Preparing QA Datasets

One (1) CCTA and One (1) SPECT MPI should be submitted to ACRIN core lab for qualificationOne (1) CCTA and One (1) SPECT MPI should be submitted to ACRIN core lab for qualification For sites with inadequate studies, the ACRIN core lab will review the protocol recommendations with the site, and request an additional study until the site fulfills all requirementsFor sites with inadequate studies, the ACRIN core lab will review the protocol recommendations with the site, and request an additional study until the site fulfills all requirements Once a modality’s requirements are met, an ACRIN Imaging Technologist will send a modality specific approval letter via to the site Study CoordinatorOnce a modality’s requirements are met, an ACRIN Imaging Technologist will send a modality specific approval letter via to the site Study Coordinator Once all imaging modalities are approved, the RESCUE PM will send an official letter of acceptance for accrual via to the site Study CoordinatorOnce all imaging modalities are approved, the RESCUE PM will send an official letter of acceptance for accrual via to the site Study Coordinator

CCTA Quality Control Procedures

Image Transmittal Worksheet (ITW) must be fully completed & submitted for every CCTA exam Image Transmittal Worksheet (ITW) must be fully completed & submitted for every CCTA exam Datasets should be consistent with Diagnostic Testing Protocol Recommendations Datasets should be consistent with Diagnostic Testing Protocol Recommendations ACRIN Image Technologists will complete Quality Control (QC) form, review data for completeness of dataset, and quality of images ACRIN Image Technologists will complete Quality Control (QC) form, review data for completeness of dataset, and quality of images 19

CCTA Image Transmittal Worksheet (ITW) Form  The ITW Form contains study- specific information (i.e., Subject ID, Scan Date, Image Details  Once images have been uploaded to TRIAD, the ITW should be faxed to ACRIN  This form indicates that the images are on TRIAD and ready for evaluation by ACRIN

CCTA Quality Assessment:CCTA Quality Assessment: Absence of major motion artifacts Absence of major motion artifacts Sufficient contrast enhancement Sufficient contrast enhancement <15 mSv radiation dose <15 mSv radiation dose 21

CCTA Completeness: ITW ITW Scout Scout Dose Report Dose Report Prospective gated non-contrast Calcium Score series (optional) Prospective gated non-contrast Calcium Score series (optional) Prospectively or retrospectively gated contrast enhanced scan Prospectively or retrospectively gated contrast enhanced scan If global and regional LV function is assessed, use of multiphase axial reconstructions (1.5mm) throughout cardiac cycle are required If global and regional LV function is assessed, use of multiphase axial reconstructions (1.5mm) throughout cardiac cycle are required If routinely performed at your site, a full field of view chest scan for incidental findings If routinely performed at your site, a full field of view chest scan for incidental findings

CCTA Core Lab, the Cardiovascular Imaging Core Lab (CVIC) at Massachusetts General Hospital CCTA Core Lab at MGH will assist ACRIN in the development of general and specific protocol recommendations.CCTA Core Lab at MGH will assist ACRIN in the development of general and specific protocol recommendations. The CCTA images from the first two study subjects at each site will be reviewed by the Core Lab at MGH as well as a random sample of 10% of all cases thereafter.The CCTA images from the first two study subjects at each site will be reviewed by the Core Lab at MGH as well as a random sample of 10% of all cases thereafter. CCTA questions related to image acquisition or interpretationCCTA questions related to image acquisition or interpretation Erin Corsini, Clinical Research Associate, Cardiovascular Imaging Core Lab, MGHErin Corsini, Clinical Research Associate, Cardiovascular Imaging Core Lab, MGH

SPECT MPI Quality Control Procedures

Image Submission for QA and Trial data Images are sent to ACRIN electronically via TRIAD (de-identified data sets) Images are sent to ACRIN electronically via TRIAD (de-identified data sets) ACRIN requests submission of images within 5 days of test ACRIN requests submission of images within 5 days of test RAW, Data (Rest and Stress) in DICOM format are evaluated along with results pages RAW, Data (Rest and Stress) in DICOM format are evaluated along with results pages 100% Qualitative Evaluation is to be performed by qualified ACRIN Technologists 100% Qualitative Evaluation is to be performed by qualified ACRIN Technologists ACRIN Technologists will provide feedback as ACRIN Technologists will provide feedback as needed to sites on image quality and data completeness

SPECT Image QA/QC Criteria for SPECT Submissions: Completeness: Completeness: Rest and Stress images with complete coverage of the LV Rest and Stress images with complete coverage of the LV Screen Captures of processed results pages Screen Captures of processed results pages Beat Length Histogram (if available) Beat Length Histogram (if available) Quality: Quality: High-quality raw data projection images with attention to minimal High-quality raw data projection images with attention to minimal motion and acceptably low levels of hepatic motion and acceptably low levels of hepatic and bowel uptake and bowel uptake High-quality processed SPECT data High-quality processed SPECT data High-quality gated SPECT images with attention to High-quality gated SPECT images with attention to beat-length histogram beat-length histogram

SPECT Image Submission Procedures

SPECT Image Transmittal Worksheet (ITW) Form The ITW Form contains study-specific information (i.e., Injection Times, Isotope and Activity used, etc.)The ITW Form contains study-specific information (i.e., Injection Times, Isotope and Activity used, etc.) Once images have been uploaded to TRIAD, the ITW form is faxed to ACRINOnce images have been uploaded to TRIAD, the ITW form is faxed to ACRIN This form indicates that the images are on TRIAD and ready for review by ACRINThis form indicates that the images are on TRIAD and ready for review by ACRIN personnel personnel

Image Submission Image Submission Each SPECT Scan submitted to ACRIN must contain the following datasets in DICOM format:Each SPECT Scan submitted to ACRIN must contain the following datasets in DICOM format: RAW Rest and Stress Projection and all Gated files RAW Rest and Stress Projection and all Gated files If Attenuation Correction is used, BOTH Non Attenuation- Corrected and Attenuation-Corrected images are to be submitted If Attenuation Correction is used, BOTH Non Attenuation- Corrected and Attenuation-Corrected images are to be submitted Display and/or Result Series Images in Screen Capture format Display and/or Result Series Images in Screen Capture format Beat Length Histogram (if available) Beat Length Histogram (if available) A fully completed ITW form will be faxed to A fully completed ITW form will be faxed to ACRIN once the required datasets have been uploaded to TRIAD

Collaborative SPECT Core Lab, Tufts New England Medical Center The SPECT Core Lab at Tufts New England Medical Center will assist ACRIN in the development of general and specific protocol recommendations.The SPECT Core Lab at Tufts New England Medical Center will assist ACRIN in the development of general and specific protocol recommendations. The SPECT MPI images from the first two study subjects at each site will be reviewed by the Core Lab at Tufts as well as a random sample of 10% of all cases thereafter.The SPECT MPI images from the first two study subjects at each site will be reviewed by the Core Lab at Tufts as well as a random sample of 10% of all cases thereafter. For SPECT questions relating to image acquisition or interpretation, sites may contact the SPECT MPI Core Lab Technologist, Debra Kinan, RT(N):For SPECT questions relating to image acquisition or interpretation, sites may contact the SPECT MPI Core Lab Technologist, Debra Kinan, RT(N): Phone: SPECT Core Lab Hotline: (pager)

31 Image Queries

Case Query Notification (Z5) Response Requested 32

ACRIN Core Lab Contact Information 33 Rebecca Scaven, CNMT P: (215) F: (215) Dena Flamini RT(R)(MR)(M) P: (215) F: (215) CCTASPECT Cyndi Price RT(R)(MR) P: (215) F: (215) CCTA