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	Treatment or Intervention
Breast Cancer	Drug: gadopentetate dimeglumine  Procedure: diagnostic test  Procedure: magnetic resonance imaging

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Constance Lehman, MD, PhD,  Study Chair,  Seattle Cancer Care Alliance   

Study ID Numbers:  CDR0000285698; ACRIN-6667
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058058
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08