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Histologic Diagnoses of Incidentally Detected Lesions on MRI

Sponsor
University of Arkansas (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00579735
Collaborator
(none)
0
Enrollment
48
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Histologic Diagnoses of Incidentally Detected Lesions on MRI
    Study Start Date :
    Mar 1, 2005
    Anticipated Primary Completion Date :
    Mar 1, 2009
    Anticipated Study Completion Date :
    Mar 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      21 Years and Older
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • All patients subjected to biopsy as a result of findings seen only on MRI
      Exclusion Criteria:
      • None

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • University of Arkansas

      Investigators

      • Principal Investigator: Steven E Harms, MD, University of Arkansas

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00579735
      Other Study ID Numbers:
      • 37640
      First Posted:
      Dec 24, 2007
      Last Update Posted:
      Mar 4, 2015
      Last Verified:
      Mar 1, 2015
      Keywords provided by , ,
      Breast cancer
      Additional relevant MeSH terms:
      Breast Neoplasms

      Study Results

      No Results Posted as of Mar 4, 2015