PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00004152|
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : January 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: iodinated contrast dye Procedure: computed tomography Procedure: positron emission tomography Radiation: fludeoxyglucose F 18||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||December 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|