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Use of Breast MRI for Local Staging

21 Years
Not Enrolling
Breast Cancer

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Trial Information

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.

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.

Inclusion Criteria:

- Patients who have undergone a breast MRI for staging

Exclusion Criteria:

- None

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Breast MRI will have a significant impact on patient management

Outcome Time Frame:

at time of staging

Safety Issue:


Principal Investigator

Steven E Harms, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

April 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms