Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic Completed 18 and over NCI ACRIN-6667 NCT00058058, ACRIN-6667

Objectives

1. 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.
2. 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.
3. 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).

Entry 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

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

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

Expected Enrollment

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

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.

Lehman CD, Gatsonis C, Kuhl CK, et al.: MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med 356 (13): 1295-303, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Constance Lehman, MD, PhD, Protocol chair		Ph: 206-288-2046

Registry Information
Official Title		MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
Trial Start Date		2001-02-31
Registered in ClinicalTrials.gov		NCT00058058
Date Submitted to PDQ		2003-02-12
Information Last Verified		2004-04-30
NCI Grant/Contract Number		CA080098