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About
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.
Full description
OBJECTIVES:
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
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
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
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Hematopoietic
Hepatic
Renal
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PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Primary purpose
Allocation
Interventional model
Masking
1,007 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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