NCT02236546

FDG-PET in Advanced Melanoma

FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, \[18F\]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.

Detailed description

PRIMARY OBJECTIVES: I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma. II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma. OUTLINE: Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).

Conditions

• Recurrent Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[18F]fluorodeoxyglucose	FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
OTHER	Molecular assays on biopsied tissue	Correlative studies
DEVICE	positron emission tomography	Undergo FDG-PET/CT
DEVICE	computed tomography	CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-10-01
• Completion: 2015-11-01
• First posted: 2014-09-10
• Last updated: 2017-04-13
• Results posted: 2017-04-13

Locations

1 site across 1 country: United States