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

NCT ID: NCT00003736

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2002-06-30

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: SCREENING

Interventions

motexafin gadolinium

Intervention Type: DRUG

biopsy

Intervention Type: PROCEDURE

breast imaging study

Intervention Type: PROCEDURE

comparison of screening methods

Intervention Type: PROCEDURE

magnetic resonance imaging

Intervention Type: PROCEDURE

study of high risk factors

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Principal Investigators

Mitchell Schnall, PhD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Locations

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

University of Colorado Cancer Center

Denver, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Simmons Cancer Center - Dallas

Dallas, Texas, United States

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

University of Toronto

Toronto, Ontario, Canada

Countries

United States; Canada

References

Lehman CD, Blume JD, Thickman D, Bluemke DA, Pisano E, Kuhl C, Julian TB, Hylton N, Weatherall P, O'loughlin M, Schnitt SJ, Gatsonis C, Schnall MD. Added cancer yield of MRI in screening the contralateral breast of women recently diagnosed with breast cancer: results from the International Breast Magnetic Resonance Consortium (IBMC) trial. J Surg Oncol. 2005 Oct 1;92(1):9-15; discussion 15-6. doi: 10.1002/jso.20350.

Reference Type: RESULT

PMID: 16180217 (View on PubMed)

Lehman CD, Blume JD, Weatherall P, Thickman D, Hylton N, Warner E, Pisano E, Schnitt SJ, Gatsonis C, Schnall M, DeAngelis GA, Stomper P, Rosen EL, O'Loughlin M, Harms S, Bluemke DA; International Breast MRI Consortium Working Group. Screening women at high risk for breast cancer with mammography and magnetic resonance imaging. Cancer. 2005 May 1;103(9):1898-905. doi: 10.1002/cncr.20971.

Reference Type: RESULT

PMID: 15800894 (View on PubMed)

Other Identifiers

UPCC-ACR-6884

Identifier Type: -

Identifier Source: secondary_id

UPCC -IBMC-6884

Identifier Type: -

Identifier Source: secondary_id

CDR0000066851

Identifier Type: -

Identifier Source: org_study_id