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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00579735
First Posted: December 24, 2007
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Arkansas
  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:

Enrollment: 0
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579735


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

Responsible Party: Steven E. Harms, MD, UAMS
ClinicalTrials.gov Identifier: NCT00579735     History of Changes
Other Study ID Numbers: 37640
First Submitted: December 20, 2007
First Posted: December 24, 2007
Last Update Posted: March 4, 2015
Last Verified: March 2015

Keywords provided by University of Arkansas:
Breast cancer