Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer. PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.


Study summary:

OBJECTIVES: - Determine the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer. - Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings. - Determine whether FDG-PET results in more accurate detection of disease in these patients. OUTLINE: Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months. PROJECTED ACCRUAL: (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of breast cancer for which surgical intervention is planned - Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR - Locally advanced breast cancer (T4) OR - Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR - Locally or regionally recurrent disease - No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ) - No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No known active infection - No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis) - Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics


NCT ID:

NCT00039286


Primary Contact:

Study Chair
Elisa Rush Port, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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