Download 6698 Site Imaging Manual v1.0

 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
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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
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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
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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
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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
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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.
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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.
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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.
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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).
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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
80secscantime
100sec
8minutesfollowing
injection
(a) Adjustupto400mmtoaccommodateforlargebodyhabitusifnecessary.
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