Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00058058
First received: April 7, 2003
Last updated: October 23, 2012
Last verified: April 2004
  Purpose

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.


Condition Intervention
Breast Cancer
Procedure: magnetic resonance imaging
Radiation: gadopentetate dimeglumine

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer

Resource links provided by NLM:


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

Study Start Date: February 2001
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
  • Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.
  • Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).

OUTLINE: This is a multicenter study.

Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.

Patients are followed at 12-18 and 24-30 months.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast

    • Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
  • Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
  • Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
  • Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
  • No remote history of breast cancer
  • No new breast symptoms within the past 60 days for which further evaluation is recommended
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 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

Cardiovascular

  • No pacemaker
  • No magnetic aneurysm clips

Other

  • Not pregnant
  • No implanted magnetic device
  • No severe claustrophobia
  • No other contraindications to MRI
  • No psychiatric, psychological, or other condition that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 6 months since prior anticancer chemotherapy

Endocrine therapy

  • No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058058

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Florida
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60610
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-6681
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0772
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
United States, Texas
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9085
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S 1A8
Germany
Universitaetsklinikum Bonn
Bonn, Germany, D-53105
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Chair: Constance Lehman, MD, PhD Seattle Cancer Care Alliance
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00058058     History of Changes
Other Study ID Numbers: CDR0000285698, ACRIN-6667
Study First Received: April 7, 2003
Last Updated: October 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
invasive ductal breast carcinoma
invasive lobular breast carcinoma
breast cancer in situ
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014