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Home > "P" Clinical Trials Conditions > Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
For Condition: recurrent breast cancer,stage 3A breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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: A total of 100 patients (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElisaPort, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Elisa Port 212-639-5461
Additional Information:
Study ID Numbers: CDR0000069369; MSKCC-01134,NCI-G02-2074
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039286
Other Stage 2 Breast Cancer Studies:
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2. Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
3. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
4. CP-724,714 in Treating Patients With Metastatic Breast Cancer
5. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
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Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
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