This trial is active, not recruiting.

Condition breast cancer
Treatments motexafin gadolinium, biopsy, breast imaging study, comparison of screening methods, magnetic resonance imaging, study of high risk factors
Sponsor University of Pennsylvania
Collaborator National Cancer Institute (NCI)
Start date June 1999
Trial size 200 participants
Trial identifier NCT00003736, CDR0000066851, UPCC -IBMC-6884, UPCC-ACR-6884


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose screening

Eligibility Criteria

Female participants at least 25 years old.

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

Additional Information

Official title Pilot Study: High Risk Breast Cancer Screening Pilot Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).