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Pilot Diagnostic Study of Fludeoxyglucose F 18 Positron Emission Tomography for Preoperative Evaluation of Women With Primary or Recurrent Breast Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Diagnostic | Completed | Not specified | MSKCC-01134
NCI-G02-2074, NCT00039286 |
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.
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:
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: - See Disease Characteristics
Endocrine therapy: Radiotherapy: Surgery: - See Disease Characteristics
Patient Characteristics:
Age: Sex: Menopausal status: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: 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
Expected Enrollment 100A total of 100 patients (50 with primary disease and 50 with recurrent
disease) will be accrued for this study within 1-2 years. 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.
Trial Contact Information
Trial Lead Organizations Memorial Sloan-Kettering Cancer Center | | | | Elisa Rush Port, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma | | | Trial Start Date | | 2001-10-23 | | | Trial Completion Date | | 2009-02-10 | | | Registered in ClinicalTrials.gov | | NCT00039286 | | | Date Submitted to PDQ | | 2002-04-03 | | | Information Last Verified | | 2008-12-14 | | | NCI Grant/Contract Number | | CA08748 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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