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

NCT00003736 | Completed

• 3 other identifiers: CDR0000066851UPCC-ACR-6884UPCC -IBMC-6884
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 12

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.

Conditions

Breast Cancer

Keywords

breast cancer

Interventions

motexafin gadolinium DRUG

biopsy PROCEDURE

breast imaging study PROCEDURE

comparison of screening methods PROCEDURE

magnetic resonance imaging PROCEDURE

study of high risk factors PROCEDURE

Eligibility Criteria

• Age: 25 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

University of Toronto

Toronto, Ontario, M5S 1A8, Canada

Location

Related 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 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.

  PMID: 16180217 RESULT

• 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.

  PMID: 15800894 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

motexafin gadolinium; Biopsy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Mitchell Schnall, PhD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SCREENING
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 20, 2003
• Study Start: June 1, 1999
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

US (11); CA (1)