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This study has been withdrawn prior to enrollment.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
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Histologic Diagnoses of Incidentally Detected Lesions on MRI

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Estimated Enrollment: 200
Study Start Date: March 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

mammography clinic in Northwest Arkansas

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579735

Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Steven E Harms, MD University of Arkansas
  More Information

No publications provided

Responsible Party: Steven E. Harms, MD, UAMS
ClinicalTrials.gov Identifier: NCT00579735     History of Changes
Other Study ID Numbers: 37640
Study First Received: December 20, 2007
Last Updated: March 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014