Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003736
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Abramson Cancer Center of the University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Primary Purpose: Screening
Official Title: Pilot Study: High Risk Breast Cancer Screening Pilot Study
Study Start Date : June 1999
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 120 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003736


Locations
Layout table for location information
United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Porter Adventist Hospital
Denver, Colorado, United States, 80210
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
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Mitchell Schnall, PhD Abramson Cancer Center of the University of Pennsylvania
Publications of Results:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00003736    
Other Study ID Numbers: CDR0000066851
UPCC-ACR-6884
UPCC -IBMC-6884
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents