Histologic Diagnoses of Incidentally Detected Lesions on MRI

This study has been withdrawn prior to enrollment.
(No subjects were ever enrolled. This study was closed at the IRB.)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00579735
First received: December 20, 2007
Last updated: March 27, 2009
Last verified: March 2009

December 20, 2007
March 27, 2009
March 2005
March 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00579735 on ClinicalTrials.gov Archive Site
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Histologic Diagnoses of Incidentally Detected Lesions on MRI
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.

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
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Non-Probability Sample

mammography clinic in Northwest Arkansas

Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
200
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00579735
37640
No
Steven E. Harms, MD, UAMS
University of Arkansas
Not Provided
Principal Investigator: Steven E Harms, MD University of Arkansas
University of Arkansas
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP