Transcript Incidental Findings in Research Imaging

Incidental Findings in Research Imaging
• Incidental Finding (IF)
– Finding on a research imaging study that has
potential health importance
– Finding discovered during the conduct of research
but is beyond the aims of the research study
Wolf, et. al. J Law, Medicine & Ethics, 2008
Incidental Findings in Research Imaging
• IF Prevalence – Brain MRI
– Overall prevalence rates of 13% to 84% *
• 9 publications , 1997 to 2006
• Range of study populations, scan protocols, IF definitions
• IF prevalence classified by need for clinical referral
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No referral needed, 13% to 40.4%
Routine referral, 1.8% to 43%
Urgent referral, 0.4% to 14%
Immediate referral, 0% to 1.2%
– IF prevalence rate of 43% (2010) **
• Clinical referral /additional tests, 2.2% (5/231) (NNI=46)
• Clear medical benefit, 0.9% (2/231) (NNI=116)
*Wolf, et. al. J Law, Medicine & Ethics, 2008
**Lo, Arch Int Med, 2010; Orme, et.al. Arch Int Med, 2010
Incidental Findings in Research Imaging
• IF Classification @ CUMC Radiology – Brain MRI
– Level 1 – NO CLINICALLY SIGNIFICANT ABNORMALITY
• Examples: Minimal paranasal sinus or mastoid inflammatory
disease, chronic sinusitis, venous angioma (DVA), thornwaldt
cyst, choroid plexus cyst, pineal cyst, small arachnoid cyst,
mega cisterna magna, non-dilated ventricular asymmetry,
empty sella.
– Level 2 – MINOR FINDINGS (uncertain clinical significance,
discuss with personal physician)
• Examples: Acute sinusitis (with air/fluid levels) or mastoiditis,
non-specific patchy white matter lesions (probably chronic
ischemia in periventricular white matter, basal ganglia or
pons), chronic infarct, chronic trauma, tonsillar ectopia,
severe generalized atrophy , focal atrophy (e.g. isolated brain
stem and/or cerebellum), small meningioma (<3cm) without
edema or cranial nerve or brain stem involvement, possible
demyelinating disease (non-enhancing).
Incidental Findings in Research Imaging
• IF Classification @ CUMC Radiology – Brain MRI
– Level 3 – ABNORMAL FINDINGS (needs clinical evaluation
within 1 week)
• Examples: Aneurysm, other vascular malformation (e.g.
cavernous or AVM), brain mass or infiltrating lesion with
minimal edema or mass effect (e.g. glioma, small possible
metastases), possible acute demyelinating or inflammatory
(e.g. Lyme) disease with enhancement.
– Level 4 – ACUTE ABNORMALITY (needs emergency clinical
evaluation today)
• Examples: Acute infarct (DWI positive), acute hemorrhage
(e.g. SAH, SDH, hematoma), mass with prominent edema or
brain compression (intra- or extra-axial), acute hydrocephalus
(trans-ependymal CSF).
Incidental Findings in Research Imaging
• Potential benefits and ethical/regulatory
(“Common Rule”) obligations with IF’s
– An IF may provide early detection of an
unsuspected treatable lesion.
– Research subjects implicitly entrust aspects of
their welfare to the researcher and expect to be
informed of IF’s with health implications.
– Out of respect for persons, the subject is entitled
to information relevant to their well-being.
– The researcher is obligated to reciprocate the
subject’s willingness to give of themselves in the
interest of the research.
Incidental Findings in Research Imaging
• Potential risks and negative impact of IF’s
– Clear medical benefit of an IF rarely occurs.
– Sharing of IF’s may do more harm than good.
– False positive IF’s may cause anxiety, expense and
added risk with no clear benefit.
– False negative IF’s may lead to a false assumption
of normal health.
– The discovery, tracking and reporting of IF’s divert
resources away from the science.
– A researcher’s objective of acquiring scientific
knowledge differs from that of a clinical physician.
Incidental Findings in Research Imaging
• IRB Considerations
– Can IF’s be anticipated for a specific study?
– Will the images be valid for clinical interpretation?
– Who will identify & interpret IF’s?
– Is additional expertise needed?
– How will the significance of an IF be determined?
– Is the information potentially beneficial or harmful
to the research subject?
– What should the subject be told and how can they
be told to optimize benefit and minimize risk?
– What is described in the consent form?