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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003736
Other study ID # CDR0000066851
Secondary ID UPCC-ACR-6884UPC
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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

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