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ACRIN ACRIN Imaging Core Imaging Core

LaboratoryLaboratory

RESCUE ImagingRESCUE Imaging

•• Today we will discuss a few key points Today we will discuss a few key points related to the imaging aspect of the related to the imaging aspect of the RESCUE TrialRESCUE Trial

Purpose of image submission (QA and archive) Purpose of image submission (QA and archive) CCTA imaging details CCTA imaging details SPECT imaging details SPECT imaging details How to submit images How to submit images

(what is TRIAD)(what is TRIAD)

ACRINACRIN’’s Imaging Core Laboratory (IMC) will s Imaging Core Laboratory (IMC) will evaluate each RESCUE trial imaging datasetevaluate each RESCUE trial imaging dataset

Purpose:Purpose:•• Ensure uniformityEnsure uniformity•• High quality of test performance, image acquisition and High quality of test performance, image acquisition and

image interpretationimage interpretation

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Preparing QA DatasetsPreparing QA Datasets

•• During the pre study QA process, one (1) test image for each modDuring the pre study QA process, one (1) test image for each modality ality (that is, one for CCTA and one for SPECT MPI) will be submitted (that is, one for CCTA and one for SPECT MPI) will be submitted electronically from the sites to ACRIN core labelectronically from the sites to ACRIN core lab

•• The purpose of the QA test exam is to ensure that:The purpose of the QA test exam is to ensure that:

•• recommended protocols are followedrecommended protocols are followed•• image quality is adequateimage quality is adequate•• all technical issues related to image transmission and receipt aall technical issues related to image transmission and receipt are resolvedre resolved

•• Images that are technically challenging or where quality is consImages that are technically challenging or where quality is considered idered borderline may be delivered electronically to the respective borderline may be delivered electronically to the respective collaborative core labs (MGH for CCTA and Tufts for SPECT) for collaborative core labs (MGH for CCTA and Tufts for SPECT) for consultation with experts in each modalityconsultation with experts in each modality

•• For sites with inadequate studies, the ACRIN For sites with inadequate studies, the ACRIN core lab will review the test protocol with the site core lab will review the test protocol with the site in detail and request an additional study forin detail and request an additional study forthe modality until the site fulfills the modality until the site fulfills all requirements all requirements

CCTA Quality Control CCTA Quality Control ProceduresProcedures

Image Transmittal Worksheet (ITW) must be fully Image Transmittal Worksheet (ITW) must be fully completed & submitted for every CCTA exam completed & submitted for every CCTA exam Datasets should be consistent with the Protocol Datasets should be consistent with the Protocol RecommendationsRecommendationsACRIN Imaging Technologists will complete an image ACRIN Imaging Technologists will complete an image Quality Control (QC) form, review the dataset for Quality Control (QC) form, review the dataset for completeness and assess the quality of the images completeness and assess the quality of the images

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CCTA Image Transmittal CCTA Image Transmittal Worksheet (ITW) FormWorksheet (ITW) Form

The ITW Form contains studyThe ITW Form contains study--specific information (i.e., specific information (i.e., Subject ID, Scan Date, Image Subject ID, Scan Date, Image Series DetailsSeries DetailsOnce images have been Once images have been uploaded to TRIAD, the ITW uploaded to TRIAD, the ITW should be faxed to ACRINshould be faxed to ACRINThis form indicates that the This form indicates that the images are on TRIAD and images are on TRIAD and ready for evaluation by ACRINready for evaluation by ACRIN

CCTA Completeness: CCTA Completeness: ITW form is completed in its entiretyITW form is completed in its entiretyScoutScoutDose ReportDose ReportProspective gated nonProspective gated non--contrast Calcium Score series contrast Calcium Score series (optional)(optional)Prospectively or retrospectively gated contrast enhanced Prospectively or retrospectively gated contrast enhanced scanscanIf global and regional LV function is assessed, use of If global and regional LV function is assessed, use of multiphase axial reconstructions (1.5mm) throughout multiphase axial reconstructions (1.5mm) throughout cardiac cycle are requiredcardiac cycle are requiredIf routinely performed at your site, a full field If routinely performed at your site, a full field of view chest scan for incidental findingsof view chest scan for incidental findings

•• CCTA Quality Assessment:CCTA Quality Assessment:

Absence of major motion artifactsAbsence of major motion artifactsSufficient contrast enhancement Sufficient contrast enhancement <15 mSv radiation dose<15 mSv radiation dose

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•• CCTA Core Lab, CCTA Core Lab, the Cardiovascular Imaging Core Lab (CVIC) the Cardiovascular Imaging Core Lab (CVIC) at Massachusetts General Hospital ( MGH )at Massachusetts General Hospital ( MGH ) will assist ACRIN in the will assist ACRIN in the development of general and specific protocol recommendations.development of general and specific protocol recommendations.

•• CCTA images from the first CCTA images from the first two two study subjects at each site will be study subjects at each site will be reviewed by the Core Lab at MGH as well as a random sample of 10reviewed by the Core Lab at MGH as well as a random sample of 10% of % of all cases thereafter.all cases thereafter.

•• CCTA questions related to image acquisition or interpretation CCTA questions related to image acquisition or interpretation ee--mail: mail: rescuehelp@partners.orgrescuehelp@partners.org

•• Erin Corsini, Clinical Research Associate, Cardiovascular ImagErin Corsini, Clinical Research Associate, Cardiovascular Imaging Core ing Core Lab, MGHLab, MGH

SPECT MPI Quality SPECT MPI Quality Control ProceduresControl Procedures

Image Submission for QA Image Submission for QA and Trial dataand Trial data

Images are sent to ACRIN electronically via TRIADImages are sent to ACRIN electronically via TRIAD

ACRIN requests submission of exams within 5 days of imagingACRIN requests submission of exams within 5 days of imaging

All SPECT MPI Image data must be in DICOM formatAll SPECT MPI Image data must be in DICOM format

100% Qualitative Evaluation is to be performed by qualified 100% Qualitative Evaluation is to be performed by qualified ACRIN TechnologistsACRIN Technologists

ACRIN Technologists will provide feedback as ACRIN Technologists will provide feedback as needed to sites on image quality andneeded to sites on image quality anddata completenessdata completeness

SPECT Image QA/QCSPECT Image QA/QC

Criteria for SPECT Submissions:Criteria for SPECT Submissions:•• Completeness:Completeness:

Rest and Stress images with complete coverage of the LVRest and Stress images with complete coverage of the LVAppropriate Screen Captures of processed results page(s)Appropriate Screen Captures of processed results page(s)Beat Length Histogram (if available)Beat Length Histogram (if available)

A fully completed ITW form must accompany A fully completed ITW form must accompany everyevery exam exam submitted to ACRINsubmitted to ACRIN

•• Quality:Quality:HighHigh--quality raw data projection images with attention to quality raw data projection images with attention to minimal minimal motion and acceptably low levels of hepatic motion and acceptably low levels of hepatic and bowel uptakeand bowel uptakeHighHigh--quality processed/reconstructed SPECT quality processed/reconstructed SPECT image dataimage dataHighHigh--quality gated SPECT images with quality gated SPECT images with attention to beatattention to beat--length histogram (if available)length histogram (if available)

SPECT Image Submission SPECT Image Submission ProceduresProcedures

SPECT Image Transmittal SPECT Image Transmittal Worksheet Worksheet (ITW) Form(ITW) Form

••The ITW Form contains studyThe ITW Form contains study--specific specific information (i.e., Injection Times, Isotope information (i.e., Injection Times, Isotope and Activity used, etc.) and is used by the and Activity used, etc.) and is used by the ACRIN Imaging Technologist to evaluate ACRIN Imaging Technologist to evaluate the examthe exam

••Once images have been uploaded to Once images have been uploaded to TRIAD, the ITW form is faxed to ACRINTRIAD, the ITW form is faxed to ACRIN

••This form indicates that the images are on This form indicates that the images are on TRIAD and ready for review by ACRINTRIAD and ready for review by ACRINpersonnelpersonnel

ImageImage SubmissionSubmission

•• Each SPECT Scan submitted to ACRIN must contain the following Each SPECT Scan submitted to ACRIN must contain the following datasets in datasets in DICOMDICOM format:format:

RAWRAW projection Rest and Stress files, summed gated projection filesprojection Rest and Stress files, summed gated projection filesand all gated projection files. If attenuation correction is useand all gated projection files. If attenuation correction is used, please d, please submit submit BOTHBOTH non attenuatednon attenuated--corrected corrected and and attenuatedattenuated-- corrected corrected imagesimages

Reconstructed Rest and Stress files in the short axis, vertical Reconstructed Rest and Stress files in the short axis, vertical long, and long, and horizontal long axes. A snapshot of the reconstructed slices is horizontal long axes. A snapshot of the reconstructed slices is also also acceptableacceptable

***A snapshot displaying % defect from a commercially analytic ***A snapshot displaying % defect from a commercially analytic software system (ie, Emory Cardiac Toolbox, software system (ie, Emory Cardiac Toolbox, Cedars Sinai QPS, 4DM SPECT Corridor)Cedars Sinai QPS, 4DM SPECT Corridor)

Beat Length Histogram (if available)Beat Length Histogram (if available)

A fully completed ITW form must be submitted for every A fully completed ITW form must be submitted for every SPECT MPI caseSPECT MPI case

***Snapshot Displaying % Defect***Snapshot Displaying % Defect

A) Sites that have software that can report Total Perfusion DefeA) Sites that have software that can report Total Perfusion Defect, or TPD, are asked to answer ct, or TPD, are asked to answer Q16 A & B using the values generated by the programQ16 A & B using the values generated by the program

B) Sites that B) Sites that cannot cannot submit fully quantified values from their program can report AUTsubmit fully quantified values from their program can report AUTOMATED OMATED segmental scores based on a 17 segment model. Sites that utilizesegmental scores based on a 17 segment model. Sites that utilize the automated feature of their the automated feature of their program are asked to answer Q16C using the below conversion and program are asked to answer Q16C using the below conversion and also select that a 17 segment also select that a 17 segment model was used:model was used:For AUTOMATED segmental scores in a 17 segment model, thFor AUTOMATED segmental scores in a 17 segment model, the summed scores for stress, rest, e summed scores for stress, rest,

and difference are displayed. The summed difference score (SDS) and difference are displayed. The summed difference score (SDS) represents the extent of represents the extent of ischemia.ischemia. Since each of the 17 segments is scored from 0 (normal) to 4 (sSince each of the 17 segments is scored from 0 (normal) to 4 (severely abnormal), the everely abnormal), the maximum bad score = 17 segments x 4 = 68. So an SDS of 7 or moremaximum bad score = 17 segments x 4 = 68. So an SDS of 7 or more corresponds to > 10% corresponds to > 10% myocardium ischemic (7 / 68 = 10.3%) myocardium ischemic (7 / 68 = 10.3%)

C) Sites that C) Sites that cannot cannot submit fully quantified values from their program can report AUTsubmit fully quantified values from their program can report AUTOMATED OMATED segmental scores based on a 20 segment model. segmental scores based on a 20 segment model. Sites that use the automated feature of their program arSites that use the automated feature of their program are asked e asked to answer Q16C similar to the above 17 segment example, to answer Q16C similar to the above 17 segment example, however in order for the SDS to correspond to >= 10% ischowever in order for the SDS to correspond to >= 10% ischemia, hemia, the SDS would need to be the SDS would need to be >> 88, instead of 7. Please also select that , instead of 7. Please also select that a 20 segment model was used on Q16Ca 20 segment model was used on Q16C

**The information on this slide can also be found on the ACRIN w**The information on this slide can also be found on the ACRIN website at:ebsite at:http://www.acrin.org/PROTOCOLSUMMARYTABLE/ACRIN4701RESCUE/4701Imhttp://www.acrin.org/PROTOCOLSUMMARYTABLE/ACRIN4701RESCUE/4701ImagingMaterials.aspxagingMaterials.aspx

Collaborative SPECT Core Collaborative SPECT Core Lab, Tufts New England Lab, Tufts New England

Medical CenterMedical Center

•• The SPECT Core Lab at Tufts Medical Center will assist ACRIN in The SPECT Core Lab at Tufts Medical Center will assist ACRIN in the the development of general and specific protocol recommendationsdevelopment of general and specific protocol recommendations

•• The SPECT MPI images from the first two SPECT MPIThe SPECT MPI images from the first two SPECT MPI-- randomized study randomized study subjects at each site will be reviewed by the Core Lab at Tufts subjects at each site will be reviewed by the Core Lab at Tufts as well as a as well as a random sample of 10% of all cases thereafterrandom sample of 10% of all cases thereafter

•• For SPECT questions relating to image acquisition or interpretatFor SPECT questions relating to image acquisition or interpretation, sites ion, sites may contact the SPECT MPI Core Lab Technologist, Debra Kinan, RTmay contact the SPECT MPI Core Lab Technologist, Debra Kinan, RT(N):(N):

Email: Email: dkinan@tuftsmedicalcenter.orgdkinan@tuftsmedicalcenter.org

Phone: 617Phone: 617--636636--23572357

SPECT Core Lab Hotline: 617SPECT Core Lab Hotline: 617--604604--4848 (pager)4848 (pager)

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Image QueriesImage Queries

•• Case Query Case Query Notification (Z5)Notification (Z5)

•• Response Requested Response Requested in 5in 5--10 business days10 business days

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TRIAD: TRIAD: TRTRansfer of ansfer of IImage and mage and AArchive rchive DDataata

•• TRIAD is the American College of Radiology Imaging TRIAD is the American College of Radiology Imaging NetworkNetwork’’s (ACRIN) image acquisition and s (ACRIN) image acquisition and management software.management software.

•• TRIADTRIAD--OA offers a webOA offers a web--based software solution based software solution which offers sites participating in the RESCUE trial a which offers sites participating in the RESCUE trial a secure electronic transfer method to review and secure electronic transfer method to review and submit clinical trial imagessubmit clinical trial images

•• For a more detailed explanation of the capabilities For a more detailed explanation of the capabilities and benefits of TRIAD, you may visit the TRIAD and benefits of TRIAD, you may visit the TRIAD learning center at: learning center at: https://triad.acr.org/https://triad.acr.org/

TRIAD REGISTRATIONTRIAD REGISTRATIONandand

DEPLOYMENTDEPLOYMENT

TRIAD Deployment:TRIAD Deployment:Identifying Key IndividualsIdentifying Key Individuals

•• It is helpful to identify the following key It is helpful to identify the following key individuals at your site: individuals at your site:

•• TRIAD userTRIAD user –– the individual(s) who will use TRIAD regularly the individual(s) who will use TRIAD regularly (ie, study coordinator, technologist)(ie, study coordinator, technologist)

•• IT contactIT contact –– the individual(s) who will assist with the basic the individual(s) who will assist with the basic installation and testing of the TRIAD software installation and testing of the TRIAD software

•• PACS administrator (if necessary)PACS administrator (if necessary) –– the individual(s) who the individual(s) who will assist with transporting case images from the will assist with transporting case images from the scanner/PACS system to TRIAD scanner/PACS system to TRIAD

TRIAD DEPLOYMENT:TRIAD DEPLOYMENT:Identifying Key Computers/WorkstationsIdentifying Key Computers/Workstations

•• After the individuals who will use TRIAD are After the individuals who will use TRIAD are identified, the next step in the deployment process is identified, the next step in the deployment process is to:to:

•• Identify the computer(s) you would like TRIAD installed Identify the computer(s) you would like TRIAD installed This PC does NOT have to be dedicated to TRIADThis PC does NOT have to be dedicated to TRIAD

•• Determine a time and date that would work best to schedule Determine a time and date that would work best to schedule the TRIAD installation the TRIAD installation

•• Register for a TRIAD account Register for a TRIAD account –– this may be this may be done by clicking on the following link: done by clicking on the following link:

https://triad.acr.org/Web/UserAccount/Register.aspxhttps://triad.acr.org/Web/UserAccount/Register.aspx

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TRIAD Installation TRIAD Installation & &

Sample Data TransferSample Data Transfer

••Prior to a TRIAD Prior to a TRIAD installation, when installation, when registering for your user registering for your user name/password, this name/password, this screen will appear screen will appear asking your role in the asking your role in the trial, credentials, etc.trial, credentials, etc.

TRIAD INSTALLATIONTRIAD INSTALLATION

•• Once your site is ready to proceed with the TRIAD Once your site is ready to proceed with the TRIAD installation, please submit an einstallation, please submit an e--mail to mail to TRIADTRIAD--Support@phila.acr.orgSupport@phila.acr.org

•• Include the following information with your eInclude the following information with your e--mail: mail:

date and time you would like the installation to take placedate and time you would like the installation to take place

individual(s) who plan to participate in the installationindividual(s) who plan to participate in the installation

site name and numbersite name and number

contact informationcontact information

•• The TRIAD setup at your site is customizable with The TRIAD setup at your site is customizable with two (2) basic options for submission of images two (2) basic options for submission of images originating from, or routed through, the Clinical Site:originating from, or routed through, the Clinical Site:

•• TRIAD ClientTRIAD Client•• TRIAD Site ServerTRIAD Site Server

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Selecting TRIAD OptionsSelecting TRIAD Options

TRIAD ClientTRIAD Client

•• The installation of TRIAD client application The installation of TRIAD client application is preferred:is preferred:

For submission of images directly from CD or For submission of images directly from CD or folders folders

Recommended for low volume sitesRecommended for low volume sites•• Fewer than five (5) CCTA submissions/monthFewer than five (5) CCTA submissions/month

TRIAD Site ServerTRIAD Site Server

•• The installation of TRIAD client application The installation of TRIAD client application and TRIAD site server is preferred:and TRIAD site server is preferred:

For submission of images transferred directly from For submission of images transferred directly from a sitea site’’s PACS or Scanner on the same local area s PACS or Scanner on the same local area networknetwork

Recommended for high volume sitesRecommended for high volume sites•• Greater than Five (5) or more CTA Greater than Five (5) or more CTA

submissions/monthsubmissions/month

TRIAD Client Hardware and TRIAD Client Hardware and Network Requirements:Network Requirements:

•• Model: PC Model: PC •• Processor: Intel PProcessor: Intel P--IV 3 GHz minimum, Intel Core 2 Duo 2GHz is IV 3 GHz minimum, Intel Core 2 Duo 2GHz is

recommendedrecommended•• RAM: 1GB is minimum, 4GB is recommendedRAM: 1GB is minimum, 4GB is recommended•• HDD: 200Mb for Rich GUI client application itself up to 200GbHDD: 200Mb for Rich GUI client application itself up to 200Gb--

for local image cache, its size will depend on amount of images for local image cache, its size will depend on amount of images stored by the system stored by the system

•• Video: Graphic adapter and Monitor with True Color mode Video: Graphic adapter and Monitor with True Color mode support 1024 x 768 pixels x 32 bit color modesupport 1024 x 768 pixels x 32 bit color mode

•• Supported Operating systems and Software Requirements: Supported Operating systems and Software Requirements: Workstation running Rich GUI client must be: MS Windows XP Workstation running Rich GUI client must be: MS Windows XP SP3, MS Windows 7, MS.NET Framework 3.5 SP3, MS Windows 7, MS.NET Framework 3.5

•• Network Requirements: Internet connectionNetwork Requirements: Internet connection•• Minimum Client connection speed should be Minimum Client connection speed should be

at least 256 kbpsat least 256 kbps•• Desired connection speed is 1 MbpsDesired connection speed is 1 Mbps

TRIAD Site Server Supported TRIAD Site Server Supported Operating Systems and SoftwareOperating Systems and Software

RequirementsRequirements

•• Windows XP SP3, Windows 7 and Windows Server Windows XP SP3, Windows 7 and Windows Server 2003 SP22003 SP2

•• Microsoft.NET Framework 3.5 ,SQL Express 2005Microsoft.NET Framework 3.5 ,SQL Express 2005

•• SOFTWARE REQUIREMENTSSOFTWARE REQUIREMENTSModel: PC Model: PC Processor: Intel PProcessor: Intel P--IV 3GHz minimum, Intel Core 2 Duo 2GHz IV 3GHz minimum, Intel Core 2 Duo 2GHz is recommendedis recommendedRAM: 1GB minimum, 4GB is recommended RAM: 1GB minimum, 4GB is recommended HDD: Its size depends on amount of images HDD: Its size depends on amount of images received from the scanner before they are received from the scanner before they are sent to TRIAD sent to TRIAD Image Storage100 Gb minimum, Image Storage100 Gb minimum, 200Gb is recommended200Gb is recommended

TRIAD Letter TRIAD Letter & &

Consultation CallConsultation Call

•• TRIAD Greeting Letter is sent (via eTRIAD Greeting Letter is sent (via e--mail) to Site Study mail) to Site Study CoordinatorCoordinator

•• The letter prepares your organization by providing The letter prepares your organization by providing requirements for the installationrequirements for the 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 Site Study Coordinator should be prepared to confirm the

following information:following information:Installation plan/process for image transferInstallation plan/process for image transferNumber of TRIAD installs requiredNumber of TRIAD installs required

•• TRIAD Installation occurs on scheduled date/time TRIAD Installation occurs on scheduled date/time

•• Site will be required to submit a test Site will be required to submit a test exam during installation to confirm exam during installation to confirm successful TRIAD deploymentsuccessful TRIAD deployment35

ACRIN Core Lab ACRIN Core Lab Contact InformationContact Information

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Rebecca DiGati Scaven, CNMTRebecca DiGati Scaven, CNMTrscaven@acr.orgrscaven@acr.orgP: (215) 574P: (215) 574--31753175F: (215) 923F: (215) 923--17371737

CCTACCTA SPECTSPECT

Cyndi Price RT(R)(MR)Cyndi Price RT(R)(MR)cprice@acr.orgcprice@acr.orgP: (215) 940P: (215) 940--88638863F: (215) 923F: (215) 923--17371737