Basic Trial Information
|No phase specified||Diagnostic||Completed||18 and over||NCI, Other||CDR0000285698|
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.
Further Study Information
- 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.
- Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
- Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
- Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
- Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
- Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
- No remote history of breast cancer
- No new breast symptoms within the past 60 days for which further evaluation is recommended
- No magnetic aneurysm clips
- No implanted magnetic device
- No other contraindications to MRI
- No psychiatric, psychological, or other condition that would preclude informed consent
PRIOR CONCURRENT THERAPY:
- At least 6 months since prior anticancer chemotherapy
- No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)
Trial Lead Organizations/Sponsors
American College of Radiology Imaging Network
- National Cancer Institute
Constance Lehman, Study Chair
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00058058
ClinicalTrials.gov processed this data on January 22, 2015
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