Histologic Diagnoses of Incidentally Detected Lesions on MRI

Breast Cancer Clinical Trial

Official title:

Histologic Diagnoses of Incidentally Detected Lesions on MRI

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00579735
• Other study ID #: 37640
• Status: Withdrawn
• Phase: N/A
• First received: December 20, 2007
• Last updated: March 3, 2015
• Start date: March 2005
• Est. completion date: March 2009

Study information

• Verified date: March 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas