Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
- Conditions
- Breast CancerContralateral Breast Cancer
- Interventions
- Procedure: MRI
- Registration Number
- NCT00058058
- Lead Sponsor
- American College of Radiology Imaging Network
- 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
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1007
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MRI Evaluation of Contralateral Breast MRI The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.
- 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.
Trial Locations
- Locations (21)
Boca Raton Community Hospital
🇺🇸Boca Raton, Florida, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada