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

April 7, 2003
October 23, 2012
February 2001
March 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00058058 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer

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.

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.

Interventional
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Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: magnetic resonance imaging
  • Radiation: gadopentetate dimeglumine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Canada
 
NCT00058058
CDR0000285698, ACRIN-6667
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American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Constance Lehman, MD, PhD Seattle Cancer Care Alliance
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP