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SITE IMAGING MANUAL ACRIN 6698 Diffusion Weighted MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A sub-study of the I-SPY 2 TRIAL Version: 1.0 Date: May28,2012 www.acrin.org AmericanCollegeofImagingNetwork VERSIONHISTORY Version 1.0 Section ‐‐‐ SummaryofChange FinalDocument ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page2of11 AmericanCollegeofImagingNetwork TABLEOFCONTENTS 1.0 OverviewofImagingRequirements……………………………………………………..……….. 4 2.0 ImagingQualification………………………………………………………………………….......……. 4 2.1 ImagingEquipment 2.2 DWIPhantomTest 2.3 DWITestScans 2.4 DW‐MRILearningModule 2.5 QualificationReviewandNotification 2.6 ChangestoQualifiedScanner(s)and/orBreastCoil 3.0 StandardizedBreastMRI………………..…………………………………………………………..… 6 3.1 ImagineSchedule 3.2 ImagingProcedure 3.2.1 ExamPreparations 3.2.2 DWIAcquisitionProtocol 3.2.3 DWIReproducibilityScan 4.0 ManagementofImageData…….……………….……………………………………….……….….. 9 4.1 StorageofImageData 4.2 SubmissionofImageDatatoCoreLab 4.2.1 De‐identificationofImages 4.2.2 ImageTransmittalWorksheet(ITW) 5.0 QualityControl……………………………………………………………………………………………. 10 5.1 StudyImaging 5.2 DWIPhantomTests StandardizedI‐SPY2andACRIN6698MRIAcquisitionParameters(Table4)….. 11 PleaserefertotheACRIN6698webpageforthecurrentversionsofallstudydocuments, http://www.acrin.org/6698_protocol.aspx. DW‐MRIQualificationForm DWIPhantomTestInstructions ImageTransmittalWorksheet(ITW) ImagingEquipmentUpdateForm ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page3of11 AmericanCollegeofImagingNetwork 1.0 OVERVIEWOFIMAGINGREQUIREMENTS SubmitpriortoACRIN6698studyenrollment(foreachscanner): DWIQualificationForm DWIQualification DWIPhantomQCTesting 2DWITestScans 6698DW‐MRILearningModule PerformperstandardizedI‐SPY2/ACRIN6698acquisitionprotocol MRI‐1:Pre‐treatment(priortorandomization) MRI/DWI MRI‐2:Earlytreatment(endofpaclitaxelcycle3,priortocycle4) TimePoints MRI‐3:Inter‐regimen(atleast1dayafterpaclitaxel,priortoAC) MRI‐4:Pre‐surgery(atleast2‐3weeksafterAC,priortosurgery) PerformperstandardizedACRIN6698acquisitionprotocol Reproducibility MRI‐1:Preferredtimepoint(selectsitesandpatientsonly) DWI MRI‐2:IfnotperformedatMRI‐1 StandardizedQC DWIPhantomQCTestingperformedevery6months 2.0 IMAGINGQUALIFICATION ParticipationintheI‐SPY2trialandACRIN6698sub‐studyrequiresthatallsitesadhere to a standardized MR imaging protocol. The use of standard imaging guidelines is an essentialcomponentofclinicaltrialsinwhichimagingplaysacentralroleintheresearch endpoints. This is of particular importance in multicenter trials where equipment, personnel, and imaging acquisition protocols can vary significantly. Thus, the use of standardized imaging guidelines helps control the inter‐ and intra‐site variability inherentinmulticenterimagingtrials. To participate in the ACRIN 6698 sub‐study, I‐SPY 2 sites will be required to perform phantomQCtestingandsubmitatleast2DWItestscansacquiredusingthemulti‐bvalue DWI sequence provided below in Section 3. Sites must pass the qualification requirementsforatleastonescannerpriortoaccrualtoACRIN6698. Thepurposeoftheimagingqualificationprocessistohelpensuretrialimagingisofhigh qualityandperformedperthetrial‐standardizedacquisitionprotocol.Suboptimalimage quality and/or imaging not performed per the trial‐standardized protocol can result in exclusionoftheimagingexam(s)and/ortheentirecasefromanalysis.Therefore,routine QCandadherencetotheI‐SPY2andACRIN6698imageacquisitionprotocolareofgreat importance. 2.1 ImagingEquipment ConsistentwithI‐SPY2,therequiredimagingequipmentincludes: atleastone1.5Tor3TwholebodyMRIscanner adedicatedbreastradiofrequencycoil Sites are required to identify at least one 1.5T or 3T MR scanner for imaging of ACRIN 6698 study patients. An ACRIN 6698 DW‐MRI Qualification Form is required for each ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page4of11 AmericanCollegeofImagingNetwork scanner to be used for study imaging. In choosing which scanner(s) to qualify, please note that it is preferred (best practice) that all study imaging for a given patient be performedonthesamescanner.Whenthisisnotpossible,allimagingforagivenpatient mustbeperformedusingthesamescannerconfiguration(manufacturer,fieldstrength, model,andbreastcoilmodel). 2.2 DWIPhantomTest DWI phantom tests are required for each scanner to be used for study imaging. Upon receipt of the ACRIN 6698 Protocol‐Specific Application (PSA), a pair of DWI phantoms will be delivered to the site for system testing. These ice water‐based phantoms, by utilizingamediumwithaknowndiffusioncoefficientandtemperaturecontrol,providea standardized/harmonized method for DWI QC testing. The DWI Phantom Test Instructions, detailing phantom preparation and scan instructions, is available for download from the ACRIN 6698 web site, http://www.acrin.org/6698_protocol.aspx. Forimagesubmissioninstructions,refertosection4.2below. 2.3 DWITestScans TwoclinicalDWItestscansarerequiredforeachscannertobeusedforstudyimaging.The DWItestscansshouldbeacquiredperthe4b‐valueDWIacquisitionprotocolprovidedin Section3,butonlyafterreceivingACRIN‐approvaloftheDWIphantomtest.Thetestscans canbeperformedoncurrentI‐SPY2patientsorvolunteers.RefertoSection4.2forimage submissioninstructions. 2.4 DWILearningModule Aspartofthesitequalificationprocess,siteswillbeaskedtoidentifyalead/researchMRI technologisttooverseethestudy‐relatedimagingactivities.Thistechnologistisrequiredto complete a study‐specific DWI learning module. The learning module will provide an overview of the 6698 imaging requirements as well as provide information regarding image quality issues specific to DWI. Though not required, all MRI technologists working with6698studyparticipantsareurgedtocompletethelearningmodule. 2.5 QualificationReviewandNotification TheDWIdatafromboththeQCandclinicaltestscanswillbeevaluatedforgeneralimage quality (e.g. artifacts, distortion, signal‐to‐noise) and compliance with the standardized DWI acquisition protocol. Upon approval of the DWI phantom tests, ACRIN will notify sites via email to move forward with the required test scans. If the test scans are approved,ACRINwillemailascanner‐specificqualificationnotification/report.Ifthetest scans are not approved, the required technical corrections will be communicated (by email and/or phone) and another test scan, with the required corrections, should be submittedforreview.Approvalofthetestscan(s)ismandatorypriortoasiteregistering aparticipantontotheACRIN6698trial. 2.6 ChangestoQualifiedScanner(s)and/orBreastCoil Changes in the scanner or breast coil used to image I‐SPY 2 and/or ACRIN 6698 study patients should be reported immediately to the ACRIN Core Lab using the Imaging ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page5of11 AmericanCollegeofImagingNetwork Equipment Update Form (download from http://www.acrin.org/6698_protocol.aspx.). Theadditionofanewscannerorbreastcoilforstudyimagingwillrequirefullscanner qualification. Software and/or hardware upgrades to already qualified scanners will be reviewedbytheACRINImagingCoreLabtodeterminewhetheradditionalQCtestingor test scans will be required. In either case, use of a new scanner/breast coil or software/hardware upgrades, sites should consult ACRIN prior to scanning study patients. 3.0 STANDARDIZEDBREASTMRI BecauseacquisitionprotocolscanvarysignificantlyacrossinstitutionsboththeI‐SPY2and ACRIN 6698 studies make use of a standardized MR acquisition protocol. All breast MRI scans performed on ACRIN 6698 study patients should be performed per the I‐SPY 2 acquisitionprotocolwiththeexceptionoftheDWIscan,whichshouldbeperformedusing the4b‐valueDWIacquisitionprotocolprovidedbelowinsteadofthetwob‐valueI‐SPY2 DWIacquisitionprotocol.ContacttheACRINImagingCoreLaboratorywithanyquestions regardingtheimagingprotocol. 3.1 ImagingSchedule AllI‐SPY2andACRIN6698imagingshouldbeperformedatthefollowingtimepoints,as definedintheI‐SPY2protocol. Figure1.Schema MRI‐1 6698 DWI MRI‐2 6698 DWI Reproducibility DWI (If patient consented) Reproducibility DWI (If patient consented and not acquired with MRI‐1) MRI‐3 6698 DWI MRI‐4 6698 DWI ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page6of11 AmericanCollegeofImagingNetwork 3.2 ImagingProcedure As identified by the I‐SPY 2 protocol, the standardized MRI protocol includes a bilateral pre‐contrast T2‐weighted sequence, a pre‐contrast diffusion‐weighted imaging (DWI) sequence, a pre‐contrast T1‐weighted sequence, and a T1‐weighted dynamic contrast‐ enhanced (DCE) sequence. For I‐SPY 2 patients also enrolled to ACRIN 6698 the DWI sequencewillbeacquiredusingadiffusion‐weightedspinecho‐echoplanarimaging(DW SE‐EPI)sequencewith4b‐values. When setting up this acquisition protocol for the first time (e.g. for the qualification test scans) the protocol should be saved to the scanner’s protocol menu under an easily recognizable name, such as ISPY2 or ACRIN 6698; this will help avoid future confusion aboutwhichimagingprotocoltoselect.Pleasenotethatsomefacilitieslimitaccesstothe system’sprotocolmenusothismayrequirespecialuserpermissions. 3.2.1 ExamPreparations AllMRIexamsofthesamepatientmustbeperformedonanACRIN‐qualified scanner, using the same scanner (best practice) or the same scanner configuration (manufacturer, field strength, model, and breast coil model), andusingthesamecontrastagentbrand. Patientsshouldbescannedproneandcenteredtothetable. Placeanintravenouscatheterinthearmorhandpriortothestartofimaging forcontrastinjection.Sitesshouldadheretostandardclinicalguidelinesfor the safe administration of contrast media (such as pre‐testing and contrast history). PleaseuseuniversalMRIsafetyprecautions. 3.2.2 DWIAcquisitionProtocol The DWI scan must be acquired prior to the DCE sequence using a diffusion‐ weightedspinecho‐echoplanarimaging(DWSE‐EPI)sequence. Axialorientation DiffusiongradientsinthreeorthogonaldirectionstomeasureisotropicADC Parallelimaging(reductionfactor>2) Fat suppression utilizing the optimal technique (SPAIR, STIR, etc.) for the MRIscannerbeingused 4b‐values:0,100,600and800s/mm2 Acquire the maximum number of slices that can be acquired during a single acquisition(typically24‐30slices). Coverageshould beadjustedtokeepthescanwithinasingleacquisitionto minimizescantimeandmotionartifacts. TotalscandurationfortheDWIsequenceshouldbe4‐6minutes;formulti‐b‐ valueacquisition,shouldbeontheorderof5minutes. TherequiredimagingsequencesareoutlinedbelowinTable2.RefertoTable4(on page11)fordetailedacquisitionparameters. ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page7of11 AmericanCollegeofImagingNetwork Table2.AcquisitionSequences:I‐SPY2/ACRIN6698MRIProtocol Localizer/Scout Pre‐contrastT2‐weightedfastspinecho(FSE)orSTIR Pre‐contrastDWI(DWSE‐EPI) Pre‐contrast3DT1‐weightedgradientecho(GE)1 Post‐contrastdynamicmulti‐phase3DT1‐weightedGE(DCE)1 1Pre‐andpost‐contrastT1‐weightedsequencesMUSThaveidenticalimage parameterstoallowsubtraction/maps.Transmitandreceivegainsettingsshould remainconstant.Pre‐contrastT1imagesshouldbecheckedpriortocontrast injectiontoconfirmacceptablefat‐suppression. 3.2.3 DWIReproducibilityScan A subset of patients (approximately 60) will undergo a reproducibility DWI scan with MRI‐1 (preferred) or MRI‐2. For participating patients, two T2 (for DWI planning) and DWI sequences are to be acquired prior to injection of contrast for theDCEsequence. TosimulateperformanceofanentirelydistinctDW‐MRIexam,completelyremove thepatientfromthescantableafterthefirstDWIsequence,re‐positionthepatient on the table and re‐landmark, acquire a new localizer (scout), then acquire a full MRIexamperthestandardizedI‐SPY2/ACRIN6698acquisitionprotocol.DONOT endtheexamsessionafterthefirstDWIsequenceasthiswillcausemultipleexams to be created with the same accession number, which can complicate the image submissionprocess.Rather,allsequencesshouldbeacquiredwithinasingleexam session. TherequiredimagingsequencesareoutlinedbelowinTable3.RefertoTable4(on page11)fordetailedacquisitionparameters. Table3.AcquisitionSequences:DWIReproducibilitySub‐Study Localizer/Scout Pre‐contrastT2‐weightedfastspinecho(FSE)orSTIR Pre‐contrastDWI(DWSE‐EPI) RemovepatientfromMRIscannerbutDONOTexitexamsession RepositionpatientinMRIscannerandstartnewseries(sameexamsession) Localizer/Scout Pre‐contrastT2‐weightedfastspinecho(FSE)orSTIR Pre‐contrastDWI(DWSE‐EPI) Pre‐contrast3DT1‐weightedgradientecho(GE)1 Post‐contrastdynamicmulti‐phase3DT1‐weightedGE(DCE)1 1 Pre‐andpost‐contrastT1‐weightedsequencesMUSThaveidenticalimage parameterstoallowsubtraction/maps.Transmitandreceivegainsettings shouldremainconstant.Pre‐contrastT1imagesshouldbecheckedpriorto contrastinjectiontoconfirmacceptablefat‐suppression. ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page8of11 AmericanCollegeofImagingNetwork 4.0 MANAGEMENTOFIMAGEDATA 4.1 StorageofImageData Sitesareexpectedtokeepallstudydata,includingstudyimaging,foratleast7yearsafter thetrialcloses. 4.2 SubmissionofImageDatatoCoreLab AllI‐SPY2andACRIN6698imagingshouldbesubmittedtotheACRINImagingCoreLab viaTRIADwithin48hoursofacquisition.DevelopedbytheAmericanCollegeofRadiology, TRIADprovidesasecure,web‐basedmethodoftransferringandmanagingimagedata.For questions related to TRIAD contact TRIAD Support by phone at 215‐940‐8820 or email TRIAD‐[email protected]. Additionally, the TRIAD Installation Guide and TRIAD Users Guidecanbefoundonlineathttps://triad.acr.org/Learning.htm. Imaging for patients enrolled to both the I‐SPY 2 and ACRIN 6698 trials should be submittedviaTRIADundertheACRIN6698trial.I‐SPY2patientsnotenrolledtoACRIN 6698shouldcontinuetobesubmittedviaTRIADundertheI‐SPY2trial. 4.2.1 De‐identificationofImages Sites are urged not to employ the use of other de‐identification software before uploadingtheimagestoTRIADastheseapplicationsaretypicallynotdevelopedfor researchpurposesandmayremovedatapertinenttotheresearch.TRIADremoves patientinformationandreplacesitwithsiteandstudy‐specificidentifiersprovided byandatthesite.TheimplementationofTRIADanonymizationisbasedonDICOM Supplement142:ClinicalTrialDe‐IdentificationProfiles, ftp://medical.nema.org/medical/dicom/final/sup142_ft.pdf. 4.2.2 ImageTransmittalWorksheet(ITW) An ACRIN 6698 ITW must be submitted for all imaging at the time of image submission.TheITWshouldbecompletedinfullandsubmittedviaemailtoACRIN‐ [email protected]. All current study documents can be found on the ACRIN 6698website,http://www.acrin.org/6698_protocol.aspx.). 5.0 QUALITYCONTROL(QC) 5.1 StudyImaging SitesareexpectedtoacquiretheMRIexamsperthestandardizedMRacquisitionprotocol and review all imaging at the time of acquisition for basic image quality and compliance withthestandardizedacquisitionprotocol.MRtechnologistswithanyquestions/concerns regarding image quality of the study MR, as performed, should consult their study radiologist(s) prior to the patient leaving to determine whether the exam should be repeated. ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page9of11 AmericanCollegeofImagingNetwork UponreceiptoftheimagesatACRIN,aQCreviewwillbeconductedbyaqualifiedACRIN Imaging Technologist (ACRIN‐IT). The QC review includes checking for: [a] missing images/sequences, [b] appropriate level of de‐identification, [c] complete anatomical coverageofthebreastparenchyma,[d]absenceofimageartifacts,[e]scannercompliance (performed on qualified scanner, performed on same scanner or same scanner configuration), and [f] compliance with acquisition parameters. Missing or discrepant imagedatawillbecommunicatedtothesitebytheACRIN–ITviaaZ5DataQuery.Queries will be emailed to the responsible site personnel for resolution. Sites are expected to resolve data queries expeditiously. Queries not resolved within 7 business days will be categorizedasoverduedata.Allstudyimagingwillundergoanadditionalqualityreviewas partofthecentralreviewandimageanalysisprocessconductedbytheUCSFBreastMRI ResearchLaboratory. 5.2 DWIPhantomTest For each qualified scanner, sites are required to conduct DWI phantom tests every 6 monthsusingthesamephantomandtestingproceduresusedforthequalificationtesting. The DWI Phantom Test Instructions is available for download from the ACRIN 6698 web site, http://www.acrin.org/6698_protocol.aspx. The purpose of the phantom test is to provideastandardized,quantitativeprocesstoconfirmongoingMRIsystemperformance inacquisitionofdiffusionweighted(DW)imagesofthebreast. ACRINwillidentifyatestingscheduleforeachsitebasedontheapprovaldateofthesite qualificationtesting.AllphantomimagingshouldbesubmittedtotheACRINcorelabvia TRIADundertheACRIN6698study(versusI‐SPY2). ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page10of11 AmericanCollegeofImagingNetwork Table4.StandardizedI‐SPY2andACRIN6698MRIAcquisitionParameters Parameter T2‐weighted DWI Sequencetype 2Dor3Dsequence Sliceorientation Laterality Frequencydirection Phasedirection FSEorSTIR 2D Axialorsagittal Bilateral A/P R/L(axial) S/I(sagittal) 260‐360mm(axial) 180‐220mm(sagittal) 300‐360mm(axial) 180‐220mm(sagittal) 256‐512 DWSE‐EPI 2D Axial Bilateral A/P R/L GE 3D Axial Bilateral A/P R/L 260‐360mm(a) 260‐360mm 300‐360mm(a) 300‐360mm 128‐192 384‐512 256 512x512 1.4mm Activefat‐sat recommended 2000‐10000ms 70‐140ms (STIR70ms) 16 170ms(1.5T) 230ms(3.0T) 90degrees N/A 128‐192 256x256 1.7– 2.8mm Activefat‐sat > 4,000ms Minimum (50‐100ms) N/A N/A 256 512x512 1.4mm Activefat‐sat recommended 4‐10ms Minimum(fat/water in‐phasepreferable) N/A N/A 90degrees N/A 10‐20degrees Maximum N/A 4mm Variable;complete bilateralcoverage 0,100,600,800s/mm2 4‐5mm Variable;bilateral coverage;adjusttokeep w/insingleacquisition Nogap >2 > 2 N/A N/A 2.5mm 60;complete bilateralcoverage FOV–frequency FOV‐phase Matrix–frequency (acquired) Matrix–phase(acquired) ReconstructionMatrix In‐planeresolution Fat‐suppression TR TE EchoTrainLength TI(STIRsequence) FlipAngle ReadoutBandwidth (perpixel) bvalues Slicethickness(acquired) #ofslices SliceGap Parallelimagingfactor #ofexcitations/averages k‐spaceordering 1.0mm 2 2 N/A Sequence acquisitiontime Totalpost‐contrast imagingduration 7minutes 4‐6minutes (multi‐bseq~5min) N/A N/A T1‐weighted Nogap 2 2 ‐kto+k standard,non‐centric 80secscantime 100sec 8minutesfollowing injection (a) Adjustupto400mmtoaccommodateforlargebodyhabitusifnecessary. ACRIN6698SiteImagingManual,Version1.0 05‐28‐2012 Page11of11