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Histologic Diagnoses of Incidentally Detected Lesions on MRI

21 Years
Not Enrolling
Breast Cancer

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Trial Information

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

Inclusion Criteria:

- All patients subjected to biopsy as a result of findings seen only on MRI

Exclusion Criteria:

- None

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Principal Investigator

Steven E Harms, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:




Start Date:

March 2005

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Breast Neoplasms