Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
MRI Diagnostic Yield of Cancers in the Contralateral Breast	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 Outcome Measures

Name	Time	Method
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	Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the "Final BI-RADs", where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4).
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	Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.

Locations (21): Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Porter Adventist Hospital
🇺🇸
Denver, Colorado, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Walter Reed Army Medical Center
🇺🇸
Washington, District of Columbia, United States
Boca Raton Community Hospital
🇺🇸
Boca Raton, Florida, United States
Mayo Clinic
🇺🇸
Jacksonville, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸
Chicago, Illinois, United States
Memorial Medical Center
🇺🇸
Springfield, Illinois, United States
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States