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Home > "M" Clinical Trials Conditions > MRI to Detect Breast Tumors in Women

MRI to Detect Breast Tumors in Women



MRI to Detect Breast Tumors in Women

For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pennsylvania Cancer Center
Synopsis: RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast tumors. PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women who have had suspicious mammographic or clinical examinations.
Details: OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations. II. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients. III. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast. PROTOCOL OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy. Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years. PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/79 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Suspicious mammographic finding or palpable abnormality OR Suspicious clinical or ultrasound finding without associated benign mammographic features - May have more than one suspicious lesion based on mammography or clinical exam if an index lesion is present - Mammogram within 2 months prior to MRI scan and copy of films required of all patients 30 years of age and over - Eligibility maintained if patient meets above criteria and has had: Breast implant; Prior benign excisional or core biopsy at least 6 months prior to study; Fine needle aspiration performed at any time; Cancer in the contralateral breast - No history of prior breast cancer in the study breast - No benign excisional or core biopsy of the affected breast within the last 6 months --Prior/Concurrent Therapy-- - Not specified --Patient Characteristics-- - Age: 18 to 79 - Sex: Women - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No implanted pacemaker - Other: No implanted ferromagnetic device; No ferromagnetic aneurysm clip; No severe claustrophobia; No ocular metal fragments; No schrapnel injury; No difficulty lying prone; No poor venous access; No impaired decision-making abilities; Not pregnant
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MitchellSchnall,  Study Chair,  University of Pennsylvania Cancer Center

Universitaetskliniken Bonn
Bonn,  ,  D-53127
Germany
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Martin Luther Universitaet
Halle Saale,  ,  DOH-0-6112
Germany
 

University of Colorado Cancer Center
Denver,  Colorado,  80010
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

University of Toronto
Toronto,  Ontario,  M5S 1A8
Canada
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 

Cancer Center at the University of Virginia
Charlottesville,  Virginia,  22908
United States
 

Johns Hopkins Oncology Center
Baltimore,  Maryland,  21231-2410
United States
 

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 

UCSF Cancer Center and Cancer Research Institute
San Francisco,  California,  94143-0128
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104-4283
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066242;  UPCC-ACR-6883
Study Start Date: May 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003302

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