Trial Information

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

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.