next steps for lesiontracker: integration with a clinical trials … · 3 lesiontracker •...
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NextStepsforLesionTracker:IntegrationwithaClinicalTrialsWorkflowInformaticsSystem
TrinityUrbanMassGeneralHospital
June 1, 2017
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Background• Oncologyclinicaltrialsrelyonimagingtohelpdeterminepatienteligibilityandtreatmentefficacy
Solution
• Progressivelymorevariedandcomplextumormetricscriteria• Increasingdemandforsamedayturnaroundoftumormetrics• Risingexpectationsforconsistentandcontrolledresultsreporting
Challenges
Introduction
• Advancedcancerimaginginformaticstoolstopromoteprotocol-compliantimageevaluationandreviewerefficiency
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LesionTracker• QuantitativeimagingpackagebuiltonOpenHealthImagingFoundation’s(OHIF)open-sourcewebviewerandoptimizedforoncologyclinicaltrialsworkflow
• LesionTrackerisfundedbyPAR-13-294grantforAdvancedDevelopmentofInformaticsTechnology(U24)
• Vendor-neutral,extensiblezero-footprintimageviewerfordisplayandanalysisofDICOMimages
• LesionTrackerwillbeintegratedwiththePrecisionImagingMetricsclinicaltrialsinformaticsplatform(available2018)
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Commerciallypermissivesoftwarelicense(MIT)developedonGitHubandJira
OpenSourcePerformanceandfunctionalityexpectedinmodernimagingviewers
State-of-the-artFrameworkforbuildingimagingapplicationsorintegratingwith3rd-partysoftware
Extensible
ImplementsoftwarebestpracticesandQMS
ReliableRoadmapforHIPAAand21CFRPart11
SecureWeb-basedviewerusingHTML5/CSS3/ModernJavaScript
Zero-footprint
Downloadthesourcecodeat:http://github.com/OHIF/Viewersorvisithttp://lesiontracker.ohif.orgtotestdrivetheapplication
LesionTracker
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PACS Connection Protocols• SupportsDICOMmessageserviceelements(DIMSE)andDICOMwebprotocols(WADO,QIDO)
• TestedagainstOrthancanddcm4che
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Architecture• Cornerstonehttps://github.com/chafey/cornerstone• dicomParserhttps://github.com/chafey/dicomParser• Meteorhttps://www.meteor.com• MongoDBhttps://www.mongodb.com
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User Support• Communitywebmeetings(nextonJune15,2017)• PublicJirainstance:https://ohiforg.atlassian.net• Cornerstonemailinglist:https://groups.google.com/forum/#!forum/cornerstone-platform
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LesionTracker
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53%ofdevelopmentisfundedbyNCIU24
Usage and Contributions• CommercialvendorssuchasNucleusHealthhttp://www.nucleushealth.io
• StudentssuchasMGH/IACSCapstone’sSakéViewerhttp://sakeviewer.com
• HospitalresearchgroupssuchasPrecisionImagingMetricshttps://www.precisionmetrics.org
Downloadthesourcecodeat:http://github.com/OHIF/Viewersorvisithttp://lesiontracker.ohif.orgtotestdrivetheapplication
LesionTracker
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ImageAnalysis ResultsReporting
Downloadthesourcecodeat:http://github.com/OHIF/Viewersorvisithttp://lesiontracker.ohif.orgtotestdrivetheapplication
LesionTracker
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FeatureHighlights• Abilitytodefinetimepointsi.e.,
baselineorfollow-up• Longitudinal,interactive
measurementtable• Userinterface(UI)tolabellesions
consistentlyacrosspatients,trials,andsites
• Synchronizedscrollingofimagesfrommultipletimepoints
• Bi-directionalmeasurementtool • Auditlogswhichcapturesalldatachanges–who,what,andwhen
• Non-targetannotationtoolwithpre-definedresponseoptions
• Resultsreportingwithscreencapturesofannotatedimages
• Built-inresponsecriteriaconformancechecksforRECIST1.1andirRC
• UImechanismstosimplifyandaccelerateswitchingbetweenimagingstudies
ClicktoviewLesionTrackerhighlightsvideoonYouTube
LesionTracker
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LesionTracker&PrecisionImagingMetrics(PIM)
Image Analysis• Today:ClearCanvaswithcustomizedoncologyplugins
• Future:LesionTrackerwithcustomizedautomatedworkflows
Image Management• LesionTracker:Orthanc• PrecisionImagingMetrics:Nucleus.io
Workflow Management• PrecisionImagingMetricsenhancescommunicationbetweenimaging&cancercenterteamsanddrivesimageanalysis
Data Management• PrecisionImagingMetricsmanagestrialspecificdataandsupportsresponsecriteriacustomizationatthetriallevel
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In2004,Dana-Farber/HarvardCancerCenterinvestigatorswerestrugglingtogetreliable,timely,compliantassessments:
• Deviationsfromtrialprotocolparameters• Delaysinresultstooncologists(orinvestigators)• Inefficientworkflows• LackofQAandQC• Poorfiscalmanagement• Difficultyinauditpreparation
TumorImagingMetricsCore(TIMC),co-DirectedbyDrs.HarrisandVandenAbbeele,wasformedtoaddresstheseissues
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Adequateimagingassessment/reportingtoolswereonlyavailabletoClinicalResearchOrganizations(CROs),notmeetingneedsofcancercentersitereads
PIMsystemwasdevelopedbyTIMCtomanage:• Resultsreportingandprotocolcompliance• Demandingrequirementsforturnaroundtime• Communicationbetweenradiologyandoncology
Visithttp://www.precisionmetrics.orgformoreinformation
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PIMSolutionConsistsoftwointegratedapplications:
1)Workflow&datamanagementsystem 2)Imageanalysisplatform(Current)
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PIMSolutionConsistsoftwointegratedapplications:
1)Workflow&datamanagementsystem 2)Imageanalysisplatform(Future)
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PIM:TrialStaffView
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PIM:LongitudinalMetrics
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PIM:AnnotatedImages
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PIM:AnalyticalTools
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PIM:TrainingandCertification
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CancerCenter Location ActivationDate Trials TimePoints
Dana-Farber/HarvardCancerCenter
Boston,MA August2004 1,468 74,949
YaleCancerCenter NewHaven,CT September2013 358 12,612
FredHutchinsonCancerResearchCenter
Seattle,WA September2014 455 13,876
HuntsmanCancerInstitute SaltLakeCity,UT June2015 72 1,568
MasseyCancerCenter Richmond,VA September2015 54 463
WinshipCancerInstitute Atlanta,GA February2017 127 409
MedicalCollegeofWisconsin
Milwaukee,WI Summer2017 TBD TBD
CurrentPIMUsage
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20*Projected
Year
TimePo
ints
CurrentPIMUsage
*
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Summary• Mostcancercentersstruggletoobtainreliable,timely,protocolcomplianttumormetrics
• Thereisaneedforadvancedcancerimaginginformaticstools
• Implementationmayvaryacrosscancercenters• LesionTracker• PrecisionImagingMetrics
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LesionTrackerDevelopmentTeam
GordonJ.Harris,PhDPrincipalInvestigator
TrinityUrban,MA,PMPProductManager
MattLearySeniorSoftwareAnalyst
RobLewisDevelopmentConsultant
ChrisHafeyDevelopmentConsultant
ErikZiegler,PhDDevelopmentConsultant
Pleasereachouttousifyouhaveanyfollow-upquestions:[email protected]&[email protected]