MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer - Full Text View

Sponsors and Collaborators:	University of Pennsylvania National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003736

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: motexafin gadolinium Procedure: biopsy Procedure: breast imaging study Procedure: comparison of screening methods Procedure: magnetic resonance imaging Procedure: study of high risk factors

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening
Official Title:	Pilot Study: High Risk Breast Cancer Screening Pilot Study

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	200
Study Start Date:	June 1999

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003736

Locations

United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 1A8

Sponsors and Collaborators

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Study Chair:

Mitchell Schnall, PhD

University of Pennsylvania

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Study ID Numbers:	CDR0000066851, UPCC-ACR-6884, UPCC -IBMC-6884
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003736 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Photosensitizing Agents
Radiation-Sensitizing Agents
Skin Diseases

Breast Neoplasms
Motexafin gadolinium
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Motexafin gadolinium
Pharmacologic Actions
Neoplasms

Photosensitizing Agents
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Dermatologic Agents
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009