Breast Cancer Clinical Trial
MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
Summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer.
PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer.
Full Description
OBJECTIVES:
Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer.
Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer.
OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test
Prior breast cancer allowed if patient meets the greater than 25% lifetime risk
Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
25 and over
Sex:
Female
Menopausal status:
Not specified
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
Other:
No contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia
Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
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There are 12 Locations for this study
San Francisco California, 94143, United States
Denver Colorado, 80010, United States
Denver Colorado, 80210, United States
Hartford Connecticut, 06102, United States
Washington District of Columbia, 20007, United States
Buffalo New York, 14263, United States
Chapel Hill North Carolina, 27599, United States
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75235, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98195, United States
Toronto Ontario, M5S 1, Canada
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