Pilot Study: High Risk Breast Cancer Screening Pilot Study
25 Years
N/A
Female
Breast Cancer
Trial Information
Pilot Study: High Risk Breast Cancer Screening Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Screening
Principal Investigator
Mitchell Schnall, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Federal Government
Study ID:
CDR0000066851
NCT ID:
NCT00003736
Start Date:
June 1999
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Porter Adventist Hospital | Denver, Colorado 80210 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Hartford Hospital | Hartford, Connecticut 06102-5037 |
