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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

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:gjharris@partners.org&turban@partners.org