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BestPrac*ces:ClinicalandResearchIncidentalFindings
GregZaharchuk,MDPhDAssociateProfessorofRadiology
StanfordUniversityStanfordHealthcare
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FactorsInfluencingIncidentalFindings
• Bodypartscanned• Ageofpa*ents• Whethertheyhaveanypre-disposingcondi*ons– Hypertension,etc.
• Typeofscanperformed(i.e.,amountofanatomyincluded)– OOenmostofthestudyisfMRIorothersequencesnottypicallyusedfordiagnosis
• Operator’sexperience– Technologists>Students,etc.
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WhatisanIncidentalFinding?
• “anincidentalfindingisafindingconcerninganindividualresearchpar*cipantthathaspoten*alhealthorreproduc*veimportanceandisdiscoveredinthecourseofconduc*ngresearchbutisbeyondtheaimsofthestudy.”
WolfSM,etal.ManagingIncidentalFindingsinHumanSubjectsResearch:AnalysisandRecommenda*ons.JournalofLaw,Medicine&Ethics.2008;36(2):219–248.
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TwoMainModels
• Researcherreferral• Readeverything
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ConsentForms:ResearcherReferral
• Theinves*gatorsforthisprojectarenottrainedtoperformradiologicaldiagnosis,andthescansperformedinthisstudyarenotop*mizedtofindabnormali*es.Theinves*gatorsandStanfordarenotresponsibleforfailuretofindexis*ngabnormali*esinyourMRIscans.
• However,onoccasiontheinves*gatormayno*ceafindingona
MRIscanthatseemsabnormal.Whenthisoccurs,aradiologistwillbeconsultedastowhetherthefindingmeritsfurtherinves*ga*on,inwhichcasetheprincipalinves*gatoroftheresearchstudybeingconductedwillcontactyouandyourprimarycarephysicianandinformyouofthefinding.
• Thedecisionastowhethertoproceedwithfurtherexamina*onontreatmentliessolelywithyouandyourphysician.
Availableathjp://cafn.stanford.edu/index.php/Documents
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Workflow:ResearcherReferral• Someoneseessomething.
– Donotalarmsubject(!)– (Maybe)mechanismforimmediateradconsulta*on– (Maybe)screeningbyamoreseniornon-MDonsite
• Ifdeemedsignificantatthislevel,PImadeaware.• Referredtoradiologistforareport(ofsomekind)
– OOenlimited,becausenon-clinicalimagingprotocolisused• ReportgiventoPI(maybe)withrecommenda*onsforfollow-up
• Follow-upisresponsibilityofpa*ent– Includinganyincurredexpenses
*ConsensusofworkflowsfromStanfordLucasCenter,StanfordCNI,UCSF,andMGH
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Noac*onnecessary• mostcommon
PossibleSequelae
B.Kimetal.,“IncidentalFindingsonPediatricMRImagesoftheBrain,”AJNRAmericanJournalofNeuroradiology2002;23:1674-1677.
Rou*nereferral• Anatomicsequencesnot
adequatefordiagnosis• Contrastneededbutnotgiven
Urgentreferral• Follow-upinnextfewdays
Immediatereferral• Intheory,cannotwaitfor
specialistread• Leastcommon(fortunately)
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IssueswithReferrals
Stressfulforpa-entMayleadtomoretests
FinancialcostsFalseposi-ves Poten-altreatablecauses
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ALargeStudy• Meta-analysis:16studies,19,559subjects• Excludedwhitemajerlesions,silentinfarcts,andmicrobleeds,megacisternamagna,cavumseptumpellucidum,asymmetricventricles
• Prevalenceof:– Non-neoplas*cfindings2.0%(95%CI1.1-3.1%)
• Arachnoidcyst0.5%,Aneurysm0.35%,Chiari0.24%– Neoplas*cfindings0.7%(0.47-0.98%)
• Meningioma0.29%,Pitadenoma0.15%,LGG0.05%• Morecommononhigh-resolu*onstudies– 4.3%vs.1.7%
Morrisetal.Incidentalfindingsonbrainmagne*cresonanceimaging:systema*creviewandmeta-analysis,BMJ2009;339:b3016
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ASmallStudy
• ResearchMRIsesng– 23T,17T,13TPET/MRI– Circa1000humanscansperyear
• Primarilyneurobrainscans(>70%)– AlotofEPI
• Scansperformedprimarilybystudents&technologists(non-MD’sandnon-radiologists)
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IncidentalFindings• Reviewof2.5yearperiod(2013-2015)– 49/2500casesreferred,80%brain
– About2%oftotal
• 11casesrequiredcontac*ngsubject– 0.4%
• 2casesleadingtopossibleac*on– 0.1%
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CasesNotRequiringFollow-up
• Perivascularspaces,VRspaces(n=9)• Nothing(n=4)• Arachnoidcyst(n=2)• Arachnoidgranula*on(n=2)• Sinusdisease(n=2)• Whitemajerhyperintensi*es(n=2)• Pinealcys*clesion(n=2)• Normalpituitary(n=2)
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PerivascularSpacesa.k.a.Virchow-RobinSpaces
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PerivascularSpacesa.k.a.Virchow-RobinSpaces
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PerivascularSpacesa.k.a.Virchow-RobinSpaces
• CSFsignalintensity• Surroundingsmallvessels
• Usuallybilateral• Mostcommonloca*ons– Basalganglia,espputamen
– SupratentorialWM– Midbrain
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ArachnoidCyst• LocatedCSFcollec*ons• CSFsignalintensity• Canbelargeandhavemasseffect
• Maythinadjacentskull• Nounderlyingbrain*ssuechanges
• Commonloca*ons– Anteriortemporal*p(espL)– Retrocerebellar– Overfrontalconvexi*es
• Almostneverintervenedupon
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UrgentCase1
• Smallsubacutesubduralhematoma– Observa*ononly,nointerven*onperformed
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UrgentCase2
• Pituitaryadenoma/Rathke’scleOcyst– Discussionwithneurosurgeonre:possiblesurgery
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ResearcherReferralModel:Issues
• Doesnotallowpar*cipantsto“optout”ofbeinginformedaboutevenminorfindings
• Doesnotaddresspossiblesignificantfindingsthatarenotobviousenoughtobeiden*fiedbytheresearchteam– OOentechnologistorstudent
• Alterna*ves
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ReadEverythingModel
• Allscansreadbyaneuroradiologist• Example:NCANDAstudy– Studyofhealthyadolescentslookingatbrainchangesduetoalcoholconsump*on
– N=833• Abnormali*esfoundin11.4%ofcases– 6%aOerremovingmegacisternamagna,etc.– 0.4%urgentreferrals(3/833)
Pfefferbaumetal.,CerebralCortex2015;1-21.
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ReadEverythingModel
• Moreabnormali*esdetected• Mostnotrelevant• Dilemmas:– 5graymajerheterotopiasfound– Allpresumablyasymptoma*c– ?Shouldthisbereportedtochildren/parents?
• Mostsevereabnormali*esprobablyfoundatsamerateasresearcherreferralmodel
• Expensive(ifyouhavetopay)
Pfefferbaumetal.,CerebralCortex2015;1-21.
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Conclusions• Ifyouscan,youwillsee
abnormali*es• Twomainmodels,lotsofdiscre*on
inbetween• Beprepared
– Informpa*entsviaconsentprocess– Knowtheprocedureinyourlab– Workonyourpokerface
• Manywillbenormalvariantsorar*facts
• Lowindexofsuspicionforreferralforresearchers
• Youmaysavealife.• Goodluck!
IwouldliketoacknowledgeAnneSawyer/GaryGlover(StanfordLucas),BobDougherty(StanfordCNI),Pra*kMukherjee(UCSF),andSteveStufflebeam/BruceRosen(MGH)forprovidingtheircenter’spolicies.
BartLane,MD,fordescribingtheproceduresforNCANDA.
Thistalkavailable@hjp://cafn.stanford.edu/index.php/LecturesQues*ons:[email protected]