4008 ACRIN SIM V2 01022014

User Manual: 4008

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Version: Finalv.2

Date:02January2014

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SiteImagingManual

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ACRIN PA 4008

ArterialStiffnessandWaveReflectionsasDeterminantsof

RegressionofLeftVentricularHypertrophyandFibrosisAssessed

withCardiacMRIafterAorticValveReplacementforSevere

AorticStenosis

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ACRINPA4008SiteImagingManual  

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Final02January2014  pg.1of18 

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TableofContents

LetterofIntroduction…..…………………………………………………………………………………………………………..………..……….……...3

ACRINPA4008StudySchema……………………………………………………………………………………………………………………………...4

1.0OVERVIEWOFIMAGINGREQUIREMENTS…………………………………………………………………………………………….….5

2.0STUDYOBJECTIVES/SPECIFICAIMS………………………………………………………………………………………….…………….…5

2.1StudyOverview…………………………………………………………………………………………………………….……………..5

2.2PrimaryHypothesis…………………………………………………………………………………………………………..…….…..6

3.0SCANNERQUALIFICATION…………………………………………………………………………………………………………………….…6

3.1QualificationReview…………………………………………………………………………………………………………………..7

3.2VolunteerRe‐scanning………………………………………………………………………………………………………….…...7

3.3QualifyingImageSubmission……………………………………………………………….…………………………………….8

4.0ParticipantEligibility……………………………………………………………………………………………………………………………....9

4.1InclusionCriteria……………………………………………………………………………………………………..…………………9

4.2ExclusionCriteria………………………………………………………………………………………………………………..……..9

5.0ParticipantScheduling……………………………………………………………………………………………………………………….….10

6.0ParticipantPreparationforMRIImaging………………………………………………………………………………………….……10

7.0ContrastAgentAdministration…………………………………………………………………………………………………….………..10

8.0MRIStandardizedImageAcquisitionProtocol……………………………………………………………………………………....11

9.0ArterialTonometry……………………………………………………………………………………………………………………………..…17

10.0ImageSubmission………………………………………………………………………………………………………………………………...17

10.1TRIAD…………………………………………………………………………………………………………………………………….…..17

10.2ImageTransmittalWorksheet(ITW)…………………………………………………………………………………….……17

11.0ImageQualityControl(QC)………………………………………………………………………………………………………………..….18

11.1ACRINCoreLaboratoryQualityControlTechnicalReview…..…………………………………………..…………18

11.2ImageDataQueries……………………………………………………..…………………………………………………..……….18

12.0ImagingForms……………………………………………………………………………………………………………………………………...18

References………………………………………………………………………..……………………………………………………………………………….19

 APPENDIXI:Phase‐ContrastImageAcquisitionInstructions

ACRINPA4008SiteImagingManual  

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Final02January2014  pg.2of18 

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HistoryofRevisions:

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02‐Jan‐2014RevisionstoreflectAmendment3oftheProtocol.Editsmadetoeligibility

criteriaandprotocolspecificparameters.

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ACRINPA4008SiteImagingManual  

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Final02January2014  pg.3of18 

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LetterofIntroduction

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DearImagingStaff,

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ThisSiteImagingManualcontainstheimageacquisitioninstructionsfortheACRINPA4008trial:“

ArterialStiffnessandWaveReflectionsasDeterminantsofRegressionofLeftVentricular

HypertrophyandFibrosisAssessedwithCardiacMRIAfterAorticValveReplacementforSevere

AorticStenosis.”

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Tosuccessfullymeetthestudyobjectives,itiscriticalthattheCardiacMRIimagedatasetsareacquired

accordingtotheimagingprotocoldetailedinthismanual.

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QualityControl(QC)reviewoftheimageswillbeperformedbytheACRImagingCoreLaboratory.This

reviewwillbeperformedinatimelyfashion,aspartofACRINstandardoperatingprocedures.Ifany

protocoldeviationsortechnicalissuesareidentifiedduringthereview,anACRCoreLabImaging

Technologistwillcontactyoursitetoprovidefeedbackexpeditiously.Thiswillallowyoursitetomake

anynecessaryadjustmentsearlyintheconductofthestudy.

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TheACRINPA4008ImagingTeamwishestothankyouinadvanceforyourdiligenceinadheringtothe

proceduresdescribedinthismanualtoensuretheintegrityoftheimagedatacollectedforthestudy.

PleasedonothesitatetocontacttheACRINPA4008ImagingTechnologist(seecontactinformation

below)ifyouhaveanyquestions.

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Sincerely,

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DenaFlamini

ACRINPA4008ImagingAnalyst

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AmericanCollegeofRadiology

1818MarketStreet‐Suite1600

Philadelphia,PA19103

Phone:(215)940‐8880

Fax:(215)923‐1737

www.acrin.org

Dflamini@acr.org

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ACRINPA4008SiteImagingManual  

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Final02January2014  pg.4of18 

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ACRINPA4008StudySchema

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3WeeksPriortoAVR

MRIScan1:

Gad‐EnhancedCardiacMRI

ArterialTonometry

6‐MonthsPost‐AVR(±2weeks)

MRIScan2:

Gad‐EnhancedCardiacMRI

6‐MinuteWalkTest

ArterialTonometry

AorticValveReplacement:

(AVR)InstitutionalStandard

PracticeWithin8WeeksAfter

Enrollment

Day#0

Eligibility/Enrollment

ACRINPA4008SiteImagingManual  

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Final02January2014  pg.5of18 

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1.0 OverviewofImagingRequirements

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Qualification

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Submitpriortositeactivation(foreachscanner):

 ProtocolSpecificApplication(PSA);

 Submissionofoneprotocolspecificqualificationexam

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TRIADInstallation

Shouldbeinstalledpriortostudyparticipantenrollmentforsecure,

electronicsubmissionofimagingtoACRIN.

TimePointsforTrial

Examinations

 MRIScan1:(Within3weekspriortoAVR)

o Gad‐EnhancedCardiacMRIandArterialTonometry

 MRIScan2:(6monthspostAVRsurgery)

o Gad‐EnhancedCardiacMRI,6‐MinuteWalkTest,andArterial

Tonometry

ImageSubmission

ACRINPA4008imagingshouldbesubmittedelectronicallytotheACR

ImagingCoreLabviaTRIAD.Allimagingshouldbesubmittedwithin48hours

afteracquisitionandshouldincludeanImageTransmittalWorksheet(ITW).

DataQueriesACRINwillissuequeries,asneeded,basedonQCreviewofimaging.

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GeneralTrialRequirements:

 1.5TSiemensMRIscanner

 InstitutionalexpertiseincardiacMRI(establishedcardiacMRIprogram)

 Sitemustbeabletoutilizeaphased‐arraycoil

 Sitemustbeabletoutilizeapowerinjector

 Thesitemustbeabletosubmit(1)protocolspecificqualifyingexamination

 SitemustsubmitalltrialexamstoACRINwithin48hoursafteracquisition

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NOTE: ItmaybehelpfultokeepacopyofthisManualintheimagingdepartment,soall

technologistsinvolvedintheimageacquisitionofACRINPA4008areprivytotheprotocol‐required

imagingspecifications.

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2.0 StudyObjectivesandSpecificAims

2.1 StudyOverview

ACRINPA4008SiteImagingManual  

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ACRINPA4008isamulti‐institutionalprojecttoprospectivelyevaluatepotentialdeterminants

oftheregression(improvement)ofLVhypertrophyandfibrosisassessedbycardiacMRIbefore

andafterAVRforsevereaorticstenosis.Atotalof80eligibleparticipantswilljointhestudy

fromACRIN‐qualifiedinstitutionswiththerequiredtechnology.Potentialparticipantswillbe

scheduledtoundergoAVRforseveresymptomaticaorticstenosiswithin8weeksafter

enrollment.Agadolinium‐enhancedcardiacMRIscan,alongwitharterialpulsewaverecordings

andnovelnon‐contrastmyocardialtissuecharacterizationsequences(T1rhomapping),willbe

performedwithin3weeksbeforetheAVRandrepeatedapproximately6monthsafterAVR.

ThesedatawillbeusedtoassessLVmass,LVmyocardialfibrosis,arterialstiffness,andwave

reflections.Additionalproceduresinthestudywillincludearterialtonometrymeasurements,

medicalhistoryreview,bloodcollection,aquality‐of‐lifequestionnaireanda6‐minutewalk

test.

2.2 PrimaryHypothesis

Studyhypothesesincludethatarterialstiffnessandarterialwavereflectionsareassociatedwith

alesspronouncedreductionofLVmassandfibrosisandwithagreaterdegreeofresidual

fibrosisandhypertrophydespitecorrectionofaorticstenosisviaAVR.Researchersexpectto

demonstratethatarterialstiffnessandwavereflectionsareimportantdeterminantsofresidual

leftventricularhypertrophyandfibrosis(adverseprognosticmarkersassessedwithcardiac

MRI)afteraorticvalvereplacement.Thiswouldidentifyanovel,potentiallytreatable

mechanismthatcouldbetargetedwiththerapyinfuturestudiesandcanbeassessedby

cardiacimagingstudies.

Importantly,thevalueofT1rhoimagingwillbeassessedtoevaluateitsvalueindetectingthe

degreeofmyocardialfibrosisatbaselineanddegreeofreductionafterAVR,usingpost‐

gadoliniumT1‐mappingasareferencemethod.ResearchersexpecttovalidateT1rho,anovel

MRIimagingmethodthatdoesnotrequiregadoliniumcontrast,asatechniqueforthe

assessmentofmyocardialfibrosis.Thiswouldallowformyocardialfibrosis(animportant

abnormalitythatneedstobeassessedinseveralcardiacconditions)tobeimagedwithoutthe

useofgadoliniumcontrast,whichiscontraindicatedinmanypatientswhohaveadvanced

kidneyimpairment.

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3.0 ScannerQualification

ParticipationintheACRINPA4008trialrequiresthatallsitesadheretotheprotocolspecificcardiac

MRIparametersdetailedinthismanual.Theuseofstandardimagingguidelinesisanessential

componentofclinicaltrialsinwhichimagingplaysacentralroleintheresearch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‐variabilityinherentinmulticenterimagingtrials.

ACRINPA4008SiteImagingManual  

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Thepurposeofanyimagingqualificationprocessistohelpensurethetrialimagingisofhighquality

andperformedperthetrial‐standardizedacquisitionprotocol.ToparticipateintheACRINPA4008

trial,eachsitemustqualifybyfirstscanning(1)volunteerutilizingtheACRINPA4008scanning

protocolparameters(withoutaninjectionofgadoliniumcontrast).Thesubmissionofaqualifying

examprovidesanopportunitytoevaluatecompliancewithsampleimagingacquisitionprotocols

priortoparticipantrecruitmentandactualtrial‐specificprotocols.

ThequalifyingexamwillbereviewedbytheACRImagingCoreLabforbothprotocolcomplianceand

imagequality;approvalofthequalificationexamisrequiredpriortoACRINPA4008siteactivation.

Suboptimalimagequalityand/orimagingnotperformedperthetrial‐standardizedprotocolcan

resultinexclusionoftheimagingexam(s)and/ortheentirecasefromanalysis.Therefore,routineQC

andstrictadherencetotheACRINPA4008imageacquisitionprotocolareofgreatimportance,and

siteswillbeaskedtore‐scanavolunteershouldtherebeanysubstantivechangesinhardwareor

softwaretothescannerduringtheconductofthetrial.

3.1 QualificationReview

Thequalifyingexamwillbeevaluatedforimagequality(e.g.artifacts,distortion,andsignal‐

to‐noise)andcompliancewiththeprotocolspecificcardiacMRIparameters.AnACRImaging

CoreLabImagingTechnologistwillnotifythesiteoftheresultsofthequalifyingreviewviae‐

mail.E‐maildocumentationwillincludeyoursite’sStudyCoordinator(SC),sitePI,andlead

technologisttoinformthesiteteamwhetherthequalifyingexamhasbeenapproved.Ifthe

qualifyingexamisnotapproved,requiredcorrectionsforrescanningwillbeincludedinthee‐

mail.

NOTE:Approvalofthequalifyingexamismandatorypriortoyoursiteregisteringa

participantontotheACRINPA4008trial.

3.2 VolunteerRe‐scanning

Iftheinitialqualifyingexamisnotapproved,are‐scanofavolunteerwillberequireduntil

parametersforapprovalaremetforsitequalification.Uponapprovalofthequalifyingexam,

noadditionalrequalificationisrequiredunlessoneofthefollowingconditionsoccurs:

a. Newscannerbeingintroduced.

b. Majorchangestothequalifiedscanner.Amajorchangeinscannerhardwareor

softwareoccursduringthecourseofthestudy.Thiswouldincludemajorsoftware

upgrades(i.e.,asoftwareupgradethatresultinanewsoftwareprimaryversion

number)andchangestothecoilsystem,gradientsystems,orRFamplifier.Periodic

minorupdatestoexistingsoftwareversionsarenotconsideredmajorchanges.



ACRINPA4008SiteImagingManual  

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

3.3 QualifyingImageSubmission

AllqualifyingexamsinDICOMformataretobesenttotheACRImagingCoreLabonCompact

Disc(CD)orDVD.

Pleaselabelthedisk,inpermanentmarker,withthefollowinginformation:

 SiteName

 TrialName:ACRINPA4008

 DateofImaging(DD‐MMM‐YYY)



Forquestionsrelatedtoscannerqualification,pleasesendanemailto:

imagearchive@acr.org.Enter“ACRINPA4008ScannerQualification”inthesubjectline.



ShipAllQualificationImagingto:

AmericanCollegeofRadiology

1818MarketSt.,Suite1600

Philadelphia,PA19103

Attn:ACRINPA4008ScannerQualification



ACRINPA4008SiteImagingManual  

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

4.0 ParticipantEligibility

4.1 InclusionCriteria

 18yearsofageorolder

 Severesymptomaticaorticstenosis(estimatedaorticvalvearea<1cm2)

 PlannedforAVRprocedurewithin8weeksafterenrollment

 AbletohaveacardiacMRIwithin3weekspriortoAVR

 AbletotoleratecardiacMRIimagingwithgadoliniumcontrast

 Willingandabletoprovideawritteninformedconsent



4.2 ExclusionCriteria

 KnownLVejectionfraction<50%

 Previousaorticvalvereplacement

 Plannedadditionalvalverepair/replacement

 Infectiveendocarditis

 Moderateorsevereaorticvalveregurgitation

 Rhythmotherthansinusrhythm(i.e.,atrialfibrillation)

 Unstableanginainthepreviousmonth

 Pre‐operativeestimatedglomerularfiltrationrate(eGFR)<45mL/min/1.73m²ofbody

surfacearea

 Presenceofabicuspidaorticvalve,whichisassociatedwithanintrinsicaortopathy

thatmayaffectarterialloadinitsownright

 Restingheartrate>120beatsperminute,systolicbloodpressure>180mmHg,or

diastolicbloodpressure>100mmHg

 Pregnancyorintenttobecomepregnant

 Unwillingnessofthepatienttosigntheconsentform





5.0 ParticipantScheduling

Participantswillundergotwo1.5TcardiacMRIstudiesforthetrial.MRISCAN1mustbecompleted

within(3)weekspriortoAVRandMRIScan2mustbecompleted(6)monthspostAVR.



ACRINPA4008SiteImagingManual  

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

6.0 ParticipantPreparationforMRIImaging

 Preparetheparticipantaccordingtolocalstandardpractice,includinganypre‐treatmentfor

severeclaustrophobiaoranxiety.

 Confirmrenalfunctionsufficiencypriortoimaging;eGFRmustbe>30mL/min/1.73m²ofbody

surfacearea.

 Iftheparticipanthassmoked,orhadfood,alcoholorcaffeinatedbeverageswithinfour(4)

hourspriortotesting,theMRIscanforthestudywillneedtoberescheduled.

 Iftheparticipanthastakenashort‐actingnitratewithinfour(4)hourspriortotesting,theMRI

scanforthestudywillneedtoberescheduled

NOTE:aninclusioncriterionforthetrialisthepresenceofeGFR>45mL/min/1.73m²ofbody

surfacearea.ThisistominimizethepossibilityofeGFRdroppingto<30mL/min/1.73m²bythe

timeofthe2nd(final)MRI6monthspost‐AVR.ShouldasubjectdemonstrateaeGFR<30

mL/min/1.73m²atthetimeofthefinalMRI(6‐monthspost‐AVR),thesubjectshouldundergo

theMRIbutcontrastadministration,perfusionimaging,anddelayedenhancementinversion

recoverysequencesshouldnotbeperformed.Inthisinstance,variousotherMRImeasurements

willstillbeusefulforsomestudyend‐points(forinstance,LVmass).

 SamesizeandplacementoftheintravenouscatheterisrecommendedforbothMRIscans.

Optimally,eachparticipantshouldreceiveanintravenouscatheterwithagaugenosmaller

than20gauge.

 Theparticipantwillbeplacedsupineinthemagnet;armsatsideareacceptable.Thephased‐

arraycoilshouldbeplacedandtheparticipantshouldbelocalizedperinstitutionalstandard

practice.

 Initiateimaging…



7.0 ContrastAgentAdministration

 Eachparticipantshouldreceiveanintravenouscatheternosmallerthan20gauge

 MultiHanceshouldbeadministeredinadynamicfashionwithapowerinjectoratbothtime

points.

 Forthedynamicsequence,MultiHanceshouldbeadministeredintravenouslyatadoseof0.15

mmol/kgofbodyweightandrateof2ml/second,followedbya20mlsalineflush.

Thetype,amount,rateofinjection,andsite/gaugeofIVshouldcomplywiththestudy

guidelinesandshouldbedocumentedbythetechnologistontheMRIAssessmentform.

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ACRINPA4008SiteImagingManual  

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

NOTE:KeepinmindthatthesamedoseandrateofMultiHance,samearm,andsamerateof

contrastadministrationshouldbemaintainedforbothMRIScan1and2.



8.0 MRIStandardizedImageAcquisitionProtocol

BothMRIScan1and2ACRINPA4008imagingprotocolwillincludea:

 LocalizerSeries

o 3‐planelocalizersSSFP(BHexpiration)

o AxialthoracicsingleshotaxialscoutSSFT(Non‐BH)

o HASTEthoracicFatsat(fromlowernecktobelowcosto‐phrenicangles)(Non‐BH)

o Double‐obliquelong‐axisLVplane,e.gpseudoVLAandHLAviewsSSFP(pseudoscout)

(BH‐expiration)

o ShortaxisLVplanesfrombasetoapex(pseudoscout)(BH‐expiration)



 PRE‐GADAcquisitions:



 TI‐ScoutLook‐Lockerinversionrecoveryacquisitionofamid‐ventricularshort‐axisLVview.

Therewillbebothalongandashortbreath‐holdTIScoutimageacquisition.NOTE:All

subsequentmid‐ventricularshortaxisviewsshouldbedoneatthislevel.Approximatelyten

imagesneedtobeacquiredsequentiallyatincreasinginversiontimes.

Note:Askthepatienttodohisbesttoholdhis/herbreathonthelongbreathhold,lettingthem

knowitwilllikelybedifficultandiftheyhaveto,lettheairoutoftheirlungsslowlybeforethey

breath.Iftheyareunabletoholdtheirbreathforthelongbreathholdsequence,itisvery

importanttheydotheirbesttoholditontheshortbreathholdsequence.

o RecommendedParameters:

 Increasinginversiontimes:approximately50to1,000ms

 Slicethickness:6mm

 Baseresolution:192

 Phaseresolution:50%



 SH‐MOLLIacquisitionofT1maps(mid‐ventricularshort‐axisview,samesliceastheTI‐scout)

usingsingle‐shot,modifiedLook‐Lockerinversionrecoverysequence.(BH‐expiration)

o RecommendedParameters:

 Slicethickness:6mm

 Baseresolution:192

 Phaseresolution:81%

 PartialFourier:6/8

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ACRINPA4008SiteImagingManual  

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Final02January2014  pg.12of18 



 T1RhoMAPAcquisitionT1rhomyocardialmaps(mid‐ventricularshort‐axisview,samesliceas

TImapabove)usingvariousspin‐locktimesinordertoreconstructT1rhomaps.Therewillbe

bothalongandashortbreath‐holdT1RhoMAPimageacquisition.(BH‐expiration).

o RecommendedParameters:

 Variousspin‐locktimes:10‐50ms

 Slicethickness:8mm



 MultiHanceInjection:0.15mmol/kgofbodyweightatarateof2ml/second,followedbya20

mlsalineflush.Beforeinjection,setupturboflashdynamicperfusionsequence,shortaxis,at

thesamelocationastheTIscout.Justbeforeinjection,starttheperfusionsequenceandthen

injectcontrast.Donotchangeanyparameters.



 POST‐GADAcquisitions:



 Sequentialcontiguousshort‐axiscinescoveringtheLVfrombasetotheapexwiththe

useofbreath‐holdcinesteadystatefreeprecessionsequence(SSFP).1.QueSaxslice.

2.Hit“SCAN,”DONOTuse“APPEND”3.Presscontrol‐3or4toshiftby1slicetoward

theapex4.RepeatuntilfullLVcoverage.Note1:Control‐4or3shiftsbackwards

towardsthebase.Note2:Ifpoorquality(breathing,artifactsetc.)repeatscanAND

discardthepoorqualityimage(fromthelocaldatabase).(BH‐expiration)



o RecommendedParameters:

 TR:28ms

 TE:1.18ms,

 Phases:30

 Slicethickness:8mm

 Interslicedistance:0mm

 Matrix:192x192

 IPAT:3or2(thefastestthecoilswillallowwithanacceptableimage)







 SSFPCinelong‐axisplanes(2‐,4‐,3‐chamberviewsandLVOT)

o RecommendedParameters:

 TR:30.6ms

 TE:1.3ms

 Phases:30

 Slicethickness:8mm

ACRINPA4008SiteImagingManual  

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Final02January2014  pg.13of18 



 Matrix:192x192

 IPAT:3or2(thefastestthecoilwillallowwithanacceptableimage)



 TI‐ScoutLook‐Lockerinversionrecoveryofamid‐ventricularshort‐axisLVview(same

parameters,plane,andfieldofviewasinpre‐contrastacquisition).Thissequenceallowsfor

measurementofaveragemyocardialT1time

o RecommendedParameters:

 Approximately10imagesacquiredsequentiallyatincreasinginversiontimes

(approximately50to1,000ms).



 SH‐MOLLIacquisitionofT1mapsofamid‐ventricularshort‐axisLVview(sameparameters,

plane,andfieldofviewasinpre‐contrastacquisition)usinganECG‐gatedsingle‐shotmodified

Look‐Lockerinversionrecovery(sh‐MOLLI)sequence



 Flow3chamberphasecontrastRtoLANDAtoP(twoseparateacquisitionswiththeONLY

changethedirectionoftheVENC)

o RecommendedParameters:

 TR:35.15ms

 TE:3.14ms

 Slicethickness:5.5mm

 BaseResolution:256

 PhaseResolution:50%

 IPAT:2

 Flipangle:10degrees

 Venc:130

 FlowMode:SingleDirection







 DENSEAcquisitionsofdisplacement‐encodedsequencesinamid‐ventricularshortaxis(same

slicepositionasallothersinglesliceSaximages)anda4‐chamberview

o RecommendedParameters:

 Slicethickness:8mm

 Matrix:112x112



ACRINPA4008SiteImagingManual  



Final02January2014  pg.14of18 



 TI‐ScoutLook‐Lockerinversionrecoveryofamid‐ventricularshort‐axisLVview(same

parameters,plane,andfieldofviewasinpre‐contrastacquisition).Thissequenceallowsfor

measurementofaveragemyocardialT1time.

o RecommendedParameters:

 Approximately10imagesacquiredsequentiallyatincreasinginversiontimes

(approximately50to1,000ms).

 SH‐MOLLIacquisitionofT1mapsofamid‐ventricularshort‐axisLVview(sameparameters,

plane,andfieldofviewasinpre‐contrastacquisition)usinganECG‐gatedsingle‐shotmodified

Look‐Lockerinversionrecovery(sh‐MOLLI)sequence



 TRUEFISPPSIRsingle‐shotSSFPphase‐sensitiveinversion‐recoveryacquisitionwithaninversion

timeprescribedtonullthemyocardialsignalapproximately20minutesafterthe

administrationofgadoliniumperformedincontiguousshort‐axisviews(copyprescriptionfrom

shortaxiscine).Thiswillbedonein2breathholdsalthoughcanbechangedifneeded.

o RecommendedParameters:

 Slicethickness:8mm

 Baseresolution:160

 Phaseresolution:75%.



 TURBOFLASHsegmentedphase‐sensitiveinversion‐recoveryacquisitionwithaninversiontime

prescribedtonullthemyocardialsignalimmediatelyaftertheSSFPsingle‐shortinversion

recoveryacquisition.1short‐axisslice(sameslicepositionasallothersinglesliceSax

images).Ifthereisbreathingartifact,pleaserepeattheacquisitionuntilahigh‐qualityimage

isobtained.

o RecommendedParameters:

 Slicethickness:8mm

 Baseresolution:256

 Phaseresolution:75%.



 TI‐ScoutLook‐Lockerinversionrecoveryofamid‐ventricularshort‐axisLVview(same

parameters,plane,andfieldofviewasinpre‐contrastacquisition).Thissequenceallowsfor

measurementofaveragemyocardialT1time

o RecommendedParameters:

 Approximately10imagesacquiredsequentiallyatincreasinginversiontimes

(approximately50to1,000ms)



ACRINPA4008SiteImagingManual  



Final02January2014  pg.15of18 



 SH‐MOLLIacquisitionofT1mapsofamid‐ventricularshort‐axisLVview(sameparameters,

plane,andfieldofviewasinpre‐contrastacquisition)usinganECG‐gatedsingle‐shotmodified

Look‐Lockerinversionrecovery(sh‐MOLLI)sequence



CANDY‐CANE/VENCIMAGINGFORTONOMETRYCOMPARISON

In‐planephase‐contrastacquisitionsinthe“candy‐cane”aorticview,tovisualizein‐planeflow

fordeterminationofaorticpulsewavevelocityfollowedbyshort‐axisaorticSFPcine

acquisitionsandthrough‐planeproximalaorticphase‐contrastacquisitions(whichwillbeused

formeasurementofvolumeflow).



NOTE:SeeAppendixIfordetailedphase‐contrastimageacquisitioninstructions



ACRINPA4008SiteImagingManual  



Final02January2014  pg.16of18 







ACRINPA4008SiteImagingManual  

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Final02January2014  pg.17of18 





9.0 ArterialTonometry

ApplanationtonometryshouldbeperformedimmediatelyaftertheMRIscan(inwhichphasecontrast

acquisitionsofaorticflowareacquired).Thetonometryprocedureshouldbeperformedwith

prohibitionsonsmoking,meals,andalcohol,andbeveragescontainingcaffeineforthefour(4)hours

beforemeasurements,andbeveragescontainingcaffeinefor24hoursbeforemeasurements.The

high‐fidelityMillartonometerwillbeusedtorecordbrachialandradialarterywaveformsfromthe

wristofthedominantarm.

Fordetailedprocedures,seetheArterialTonometryStandardOperatingProcedures,availableonline

atwww.acrin.org/4008_imagingmaterials.aspx



10.0 ImageSubmission

10.1 TRIAD

AlltrialexamswillbesubmittedtoACRCoreLaboratoryviaTRIAD.TRIADisasoftware

applicationthatACRINprovidesforinstallationonasite’sPC.Oneorseveralcomputersof

choicewithintheinstitutional“firewall”andontheinstitutionalnetworkmaybeequippedwith

TRIADsoftware;internetaccessisalsorequired.TheTRIADapplicationcanthenbeconfigured

asaDICOMdestinationoneitherscanner(s)and/orPACSsystemfordirectnetworktransferof

studyrelatedimagesintotheTRIADdirectory.Whenproperlyconfigured,theTRIADsoftware

anonymizes,encrypts,andperformsalosslesscompressionoftheimagesbeforetheyare

transferredtotheACRINimagearchiveinPhiladelphia.

Onceequipment‐readinesshasbeendetermined,imagingpersonnelfromACRINwill

coordinateinstallationandtrainingforthesoftware.

 TocontactTRIADSupportcall:215‐940‐8820oremailTRIAD‐Support@acr.org



10.2 ImageTransmittalWorksheet(ITW)

Allimagingshouldbesubmittedwithin48hoursafteracquisitionandshouldincludeanImage

TransmittalWorksheet(ITW).AnImageTransmittalWorksheet(ITW)isusedduringtheexam

QCreviewtoverifyacompletetransferofimagedatahasbeensubmittedtotheACRImaging

CoreLab.



ACRINPA4008SiteImagingManual  



Final02January2014  pg.18of18 



11.0 ImageQualityControl(QC)

11.1 ACRINCoreLaboratoryQualityControlTechnicalReview

UponreceiptoftheimagesattheACRImagingCoreLab,aninitialQCreviewwillbeconducted

byaqualifiedACRINImagingTechnologist.TheACRINImagingTechnologistwillcheckfor

missingimages/sequences,appropriateimageanonymization,completeanatomicalcoverage

oftheheart,adherenceofallsequencestoimagingprotocol,andabsenceofimageartifact.

Incaseswhereimagesetsarejudgedtobesuboptimal(“technicallyinadequate”),thetrialPI

willbeinformed,andareplacementparticipantwillbeaccruedfromparticipatinginstitution.

11.2 ImageDataQueries

IfitisfoundduringtheQCreviewthatthesubmittedexamhasmissingdataordoesnotfollow

theprotocolguidelines,detailedinthismanual,anImagingTechnologistwillissueaqueryto

thesiteSC.Sitesareexpectedtoresolvedataqueriesexpeditiously.Queriesnotresolved

within7businessdayswillbesenttotheACRINPA4008trialteamforadditionalfollow‐up.



12.0 ImagingForms

Thereare(2)imagingformsthatmustbecompletedandsubmittedforeachimagingtimepoint:

 ImageTransmittalWorksheet(ITW)

 MRIAssessmentForm

Itisrecommendedthateachoftheaboveformsbemadeavailable,inhardcopyformat,forthe

ImagingTechnologiststocompleteduringtheimageacquisitionwhentherequestedinformationon

theseformsismostreadilyavailable.





























































AppendixI



Phase‐ContrastImage

AcquisitionInstructions



ACRINPA4008:SiteImagingManual AppendixI





Phase‐ContrastImageAcquisitionInstructionsPage2of622May2013



 IdentifyingandPrescribingtheCandyCaneView



 Usingtheaxialstackasa3Dscoutvolume,prescribeaplanethatshowsthethoracic

aortainitslongaxis(“candycane”view,asshownbelow).

 Thisplaneshouldbeprescribedsothatitvisualizesaslargeasegmentofthethoracic

aortaaspossible.

 Inordertoprescribethisplaneproperly,findtheaxiallocalizerviewthatshowsthe

ascendinganddescendingaortaatthelevelofthepulmonaryarterybifurcationand

prescribeaplanethatpassesthroughthecenterofboththeascendinganddescending

aorta(purpleplaneinFigure1below):

Figure1:







 Then,usingtheaxiallocalizerstackviewedin3Dmode,usethecoronalplane

reconstructiontoidentifythedescendingthoracicaortaandmakesuretheplanegoes

throughthemiddleofthelumenforaslongasegmentaspossible(purpleplanein

Figure2below).Usually,thisrequiresslightcounter‐clockrotationoftheplane





















ACRINPA4008:SiteImagingManual AppendixI





Phase‐ContrastImageAcquisitionInstructionsPage3of622May2013



Figure2:







 Finally,“finetune”theplanetovisualizeaslargeasegmentoftheaortaaspossible.As

seeninFigure3below.





Figure3:







ACRINPA4008:SiteImagingManual AppendixI





Phase‐ContrastImageAcquisitionInstructionsPage4of622May2013



 CandyCaneView:ExecutionDetailsandParameterRecommendations



 Oncethisplaneisidentified,aphase‐contrastsequencewithin‐planephaseencoding

fromheadtofootwillbeacquired.Thevelocity‐encodingdirectionisrepresentedby

thebluearrowbelowinFigure4.



Figure4:

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 





Table1:CandyCaneViewParameterRecommendations

ParameterValue

Sequencetype FLASH

TR minimized(~10ms)

TE 3.2ms

Segments 1

Flipangle 30

Fieldofview ~340x340

Imagematrix 256x256

Slicethickness 8mm

Numberofslices 1

ACRINPA4008:SiteImagingManual AppendixI

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

Phase‐ContrastImageAcquisitionInstructionsPage5of622May2013



Gating Retrospective

Numberofaverages 2

VENC 130cm/sec

**prescribedad‐hoctoavoidaliasing**

Numberofphases maximized(accordingtoheartrate)

BreathingType Free‐breathing

Bandwidth 31KHz



ACRINPA4008:SiteImagingManual AppendixI





Phase‐ContrastImageAcquisitionInstructionsPage6of622May2013



 ShortAxisCineExecutionDetailsandParameterRecommendations



 One‐sliceSSFP(trueFISP)cine

 Theimagingplaneshouldbeprescribedimmediatelyabovethetopleveloftheright

pulmonaryartery,orslightlyabove,toavoidthehigh‐velocityflowclosetotheaortic

valve.

 Thesagittalscoutviewandthecandy‐caneviewshouldbeusedtoprescribethisplane.

 Theplaneshouldbeperpendiculartothelongaxisoftheaorta.

 Thegoalistoacquiretheascendinganddescendingthoracicaortaas2“circles”(See

Figure6below).

 Insomesubjects,thearchliesimmediatelycranialtotherightpulmonaryarteryand

thereforeitisnecessarytoprescribetheplaneatthelevelof(ratherthanabove)the

pulmonaryartery.

 AnapproximaterangeofacceptableprescriptionplanesisshownbelowinFigure5

(spacebetweenyellowlines),althoughparticularlyinsubjectspre‐aorticvalve

replacement,the“higherisbetter”sincehighvelocityflowfromthevalvejetisbest

avoided.



Figure5:Figure6:

  



ACRINPA4008:SiteImagingManual AppendixI





Phase‐ContrastImageAcquisitionInstructionsPage7of622May2013





Table2:ShortAxisCineParameterRecommendations

ParameterValue

SequenceType SSFP(TrueFISP)

TR <3.8ms

TE Minimized

FlipAngle 70

FieldofView 360x360

ImageMatrix 256x256

SliceThickness 8mm

NumberofSlices 1

PartialFourier Off

NumberofPhases 30

ParallelImaging(optional)GRAPPA

AccelerationFactor:2

Gating ECGRetrospective

BreathingType Breath‐hold≤15seconds





 AorticAxialCineExecutionDetailsandParameterRecommendations



 Aorticaxialoneslicephase‐contrastcinebrightblood,non‐breath‐holdsequence.

 ThesliceshouldbepositionedatexactlythesamelevelastheSSFPsequenceinthe

previoussection



Table3:AorticAxialCineParameterRecommendations

ParameterValue

Sequencetype FLASH

TR ~10msec(minimized)

TE 3.2ms

ACRINPA4008:SiteImagingManual AppendixI





Phase‐ContrastImageAcquisitionInstructionsPage8of622May2013



Segments 1

Flipangle 30

Fieldofview ~340x340

Imagematrix 256x256

Slicethickness 8mm

Numberofslices 1

Gating Retrospective

Numberofaverages 2

VENC 130cm/sec

**prescribedad‐hoctoavoidaliasing**

Numberofphases maximized(accordingtoheartrate)

BreathingType Free‐breathing













NOTE:PleasecarefullyreviewdetailsinSection6:ParticipantPreparationandSection8:

StandardizedImageAcquisitioninoftheSiteImagingManualasthisimagingprotocolmayor

maynotalignwithyourinstitution’sstandardprotocol.

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