PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to determine the extent of disease.
PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma.
|Melanoma (Skin)||Drug: iodinated contrast dye Procedure: computed tomography Procedure: positron emission tomography Radiation: fludeoxyglucose F 18||Phase 2|
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||A Pilot Study to Compare 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) Scanning in Addition to CT Scanning With CT Scanning Alone in the Pre-Operative Evaluation of Patients With Stage III and IV Melanoma|
|Study Start Date:||February 1999|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging in detecting metastatic disease in patients with stage III or IV melanoma considered for operative management based on the currently accepted diagnostic work up including CT imaging. II. Determine how often the clinical management of these patients is altered based on FDG PET imaging findings in addition to CT scan results.
OUTLINE: Patients are required to fast for a minimum of 6 hours prior to positron emission tomography (PET) imaging. Fludeoxyglucose F 18 (FDG) is administered IV over 15 minutes followed 50-60 minutes later by whole body PET imaging. Iodinated contrast dye is administered by IV injection and by mouth followed by CT imaging of the chest, abdomen, and pelvis within 2 weeks of PET imaging. Whole body FDG PET imaging and CT imaging of the chest, abdomen, and pelvis are repeated at 6 months. Initial positive PET or CT imaging results are verified based on surgical and/or biopsy findings or clinical follow-up.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 2.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004152
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Mary S. Brady, MD||Memorial Sloan Kettering Cancer Center|