Histologic Diagnoses of Incidentally Detected Lesions on MRI
Patients who received breast MRI will be evaluated for a variety of indications including ?
# each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion
clinical finding, 4)questionable mammo finding, 5)silicone leak The number of incidental
lesions not detected by any other method that were subsequently subjected to biopsy with the
following BIRADS categories 3−# reasons for bx 4−# 5−# Of the lesions detected % of each
BIRADS category were postive histologies−ductal, lobular, DCIS, etc. and negative (fibrosis,
hyperplasia, etc.) Criteria for classification: morphology, dynamics, clinical significance
will be evaluated and a predictive value established. This study is limited to retrospective
chart review with the only foreseeable risk being that of disclosure of PHI. To minimize
this risk, data collection forms will be identified by subject ID number. A master list of
these ID numbers linked to subject medical record number will be maintained in the
investigator's file and kept in a secure location accessible only to the study team for
purposes of verification of data and validation of results. The medical record number will
not be recorded on any other form containing subject PHI. The only foreseeable breach of
confidentiality would be for the security of the investigator's files to be compromised
Observational
Observational Model: Case-Only, Time Perspective: Retrospective
Steven E Harms, MD
Principal Investigator
University of Arkansas
United States: Institutional Review Board
37640
NCT00579735
March 2005
March 2009
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