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Histologic Diagnoses of Incidentally Detected Lesions on MRI

Histologic Diagnoses of Incidentally Detected Lesions on MRI

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00579735
Enrollment
0
Registered
2007-12-24
Start date
2005-03-31
Completion date
2009-03-31
Last updated
2015-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer

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.

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

Interventions

None listed

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026