Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral 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. Identifier: NCT00058058
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : October 24, 2012
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Procedure: magnetic resonance imaging Radiation: gadopentetate dimeglumine Not Applicable

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Official Title: MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
Study Start Date : February 2001
Actual Primary Completion Date : March 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No pacemaker
  • No magnetic aneurysm clips


  • 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


Biologic therapy

  • Not specified


  • At least 6 months since prior anticancer chemotherapy

Endocrine therapy

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


  • Not specified


  • 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 identifier (NCT number): NCT00058058

  Show 21 Study Locations
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Constance Lehman, MD, PhD Seattle Cancer Care Alliance

Publications of Results: Identifier: NCT00058058     History of Changes
Other Study ID Numbers: CDR0000285698
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: April 2004

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
Breast Diseases
Skin Diseases