Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
NCT ID: NCT00058058
Last Updated: 2019-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1007 participants
INTERVENTIONAL
2003-02-28
2008-08-31
Brief Summary
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PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MRI Evaluation of Contralateral Breast
The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.
MRI
Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.
Interventions
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MRI
Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Responsible Party
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Principal Investigators
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Constance Lehman, MD, PhD
Role: STUDY_CHAIR
Seattle Cancer Care Alliance
Locations
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Porter Adventist Hospital
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Boca Raton Community Hospital
Boca Raton, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Toronto
Toronto, Ontario, Canada
Universitaetsklinikum Bonn
Bonn, , Germany
Countries
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References
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DeMartini WB, Hanna L, Gatsonis C, Mahoney MC, Lehman CD. Evaluation of tissue sampling methods used for MRI-detected contralateral breast lesions in the American College of Radiology Imaging Network 6667 trial. AJR Am J Roentgenol. 2012 Sep;199(3):W386-91. doi: 10.2214/AJR.11.7000.
Weinstein SP, Hanna LG, Gatsonis C, Schnall MD, Rosen MA, Lehman CD. Frequency of malignancy seen in probably benign lesions at contrast-enhanced breast MR imaging: findings from ACRIN 6667. Radiology. 2010 Jun;255(3):731-7. doi: 10.1148/radiol.10081712.
Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. doi: 10.1056/NEJMoa065447. Epub 2007 Mar 28.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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