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Use of Breast MRI for Local Staging

This study has been withdrawn prior to enrollment.
(There were no subjects ever enrolled. Study was closed at the IRB.)
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00579319
First received: December 20, 2007
Last updated: March 27, 2009
Last verified: March 2009

December 20, 2007
March 27, 2009
April 2005
April 2009   (final data collection date for primary outcome measure)
Breast MRI will have a significant impact on patient management [ Time Frame: at time of staging ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00579319 on ClinicalTrials.gov Archive Site
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Use of Breast MRI for Local Staging
Use of Breast MRI for Local Staging

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

The medical records of patients who received breast MRI for pre—treatment staging of breast cancer will be retrospectively reviewed to see if the MRI information affected management. UAMS surgeons will be asked if the breast MRI resulted in:

  1. no change in management
  2. Moderate change in management−what (modified lumpectomy−larger or smaller)
  3. Significant change−what (contralateral breast, additional quadrants, lump to mast, neoadjuvant chemo)−note less dz than w/o MRI, more dz than w/o MRI. The medical record of patients who were imaged will be reviewed for presenting symptom, clinical exam, imaging studies (mammogram, breast ultrasound, breast MRi) and pathology results. 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

Patients undergoing breast MRI at a community practice 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
500
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have undergone a breast MRI for staging

Exclusion Criteria:

  • None
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00579319
37639
No
Steven E. Harms, MD, UAMS
University of Arkansas
Not Provided
Principal Investigator: Steven E Harms, MD UAMS
University of Arkansas
March 2009

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