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

Abramson Cancer Center at Penn Medicine

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: magnetic resonance imaging

Procedure: study of high risk factors

Procedure: biopsy

Procedure: breast imaging study

Procedure: comparison of screening methods

Drug: motexafin gadolinium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00003736

UPCC -IBMC-6884

UPCC-ACR-6884

CDR0000066851

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

25 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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