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

Breast Cancer Clinical Trial

Official title:

Pilot Study: High Risk Breast Cancer Screening Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003736
• Other study ID #: CDR0000066851
• Secondary ID: UPCC-ACR-6884UPC
• Status: Completed
• Phase: N/A
• Start date: June 1999
• Est. completion date: June 2002

Study information

• Verified date: September 2019
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• motexafin gadolinium

Procedure:
• biopsy

• breast imaging study

• comparison of screening methods

• magnetic resonance imaging

• study of high risk factors

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Porter Adventist Hospital	Denver	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Hartford Hospital	Hartford	Connecticut
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Lombardi Cancer Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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 can — View Citation

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 hig — View Citation