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Home > "D" Clinical Trials Conditions > Diagnostic Trial of Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer  Diagnostic Trial of Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Diagnostic Trial of Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: 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.
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 record of contact (ROC) 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 for approximately 30-40 minutes. Patients are followed at 12-16 and 24-30 months. PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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 - Fertile patients must use effective contraception - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ConnieLehman, Study Chair, Seattle Cancer Care Alliance
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60610
United States
Recruiting Edward Hendrick 312-695-3428
University of Toronto *Recruiting*
Toronto, Ontario, M5S 1A8
Canada
Recruiting Petrina Causer 416-978-3649
Hartford Hospital *Recruiting*
Hartford, Connecticut, 06102-5037
United States
Recruiting Michael O'Loughlin 860-545-5555
Memorial Medical Center *Recruiting*
Springfield, Illinois, 62781
United States
Recruiting Charles Neal 217-757-2055
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0772
United States
Recruiting Mary Mahoney 513-584-5335
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting Etta Pisano 919-966-6957
Seattle Cancer Care Alliance *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Connie Lehman 206-288-2046
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Susan Weinstein 215-662-4032
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Steven Harms 501-296-1161
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Gia DeAngelis 434-924-9333
Porter Adventist Hospital *Recruiting*
Denver, Colorado, 80210
United States
Recruiting Stanley Smazel 303-778-1955
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9085
United States
Recruiting Paul Weatherall 214-648-5800
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Nola Hylton 415-353-9510
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Catherine Piccoli 215-955-5330
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307
United States
Recruiting J. Choi 202-782-4330
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21287-6681
United States
Recruiting David Bluemke 410-955-4567
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Elizabeth DePeri 904-953-2000
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Nanette DeBruhl 310-794-1352
Universitaetsklinikum Bonn *Recruiting*
Bonn, , D-53105
Germany
Recruiting Christiane Kuhl 49-228-287-9876
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Thomas Julian 412-359-8720
Boca Raton Community Hospital *Recruiting*
Boca Raton, Florida, 33486
United States
Recruiting Kathy Schilling 561-395-7100
Additional Information:
Study ID Numbers: CDR0000285698; ACRIN-6667
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058058
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5. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
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Diagnostic Trial of Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
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