MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Constance Lehman, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Seattle Cancer Care Alliance
Authority:
United States: Federal Government
Study ID:
CDR0000285698
NCT ID:
NCT00058058
Start Date:
February 2001
Completion Date:
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Porter Adventist Hospital | Denver, Colorado 80210 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
| Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania 19104 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Memorial Medical Center | Springfield, Illinois 62781 |
| Boca Raton Community Hospital | Boca Raton, Florida 33486 |
