Breast Cancer Clinical Trial
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
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.
Full 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 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 21 Locations for this study
Little Rock Arkansas, 72205, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Denver Colorado, 80210, United States
Hartford Connecticut, 06102, United States
Washington District of Columbia, 20307, United States
Boca Raton Florida, 33486, United States
Jacksonville Florida, 32224, United States
Chicago Illinois, 60610, United States
Springfield Illinois, 62781, United States
Baltimore Maryland, 21287, United States
Chapel Hill North Carolina, 27599, United States
Cincinnati Ohio, 45267, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15212, United States
Dallas Texas, 75390, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98109, United States
Toronto Ontario, M5S 1, Canada
Bonn , D-531, Germany
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.