MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- American College of Radiology Imaging Network
- Enrollment
- 1007
- Locations
- 21
- Primary Endpoint
- MRI Diagnostic Yield of Cancers in the Contralateral Breast
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.
PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.
Detailed Description
OBJECTIVES: * Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam. * Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients. * Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV). OUTLINE: This is a multicenter study. Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast. Patients are followed at 12-18 and 24-30 months. PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
MRI Diagnostic Yield of Cancers in the Contralateral Breast
Time Frame: within 90 days of a negative mammogram of the study breast
To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam. the "Test" status was defined based on combinations of the following 4 factors: 1. The initial BI-RADs: from the MRI of the contralateral breast 2. The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4). 3. Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI 4. Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI
Secondary Outcomes
- MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy(within 90 days of a negative mammogram of the study breast)
- AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast(within 90 days of a negative mammogram of the study breast)