MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study: High Risk Breast Cancer Screening Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: motexafin gadolinium
* Procedure: biopsy
* Procedure: breast imaging study
* Procedure: comparison of screening methods
* Procedure: magnetic resonance imaging
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: motexafin gadolinium|nan|
|Procedure: biopsy|nan|
|Procedure: breast imaging study|nan|
|Procedure: comparison of screening methods|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer