Of 18F MEL050 Using PET/CT in Metastatic Melanoma

A Phase 0 Exploratory Microdosing Study of 6-18fluoro-N-[2-(Diethylamino)Ethyl]Pyridine-3-carboxamide (18F MEL050) Using PET/CT in Patients With Metastatic Melanoma

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.

Inclusion Criteria:

• Written informed consent obtained prior to any protocol-specific procedures
• Male and female patients with histologically confirmed melanoma
• At least one site of metastatic disease, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
• Age >/= 18 years
• Life expectancy >/=3 months
• ECOG performance score of 0-2

Exclusion Criteria:

• Pregnant or breastfeeding females
• Systemic anti-melanoma therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F MEL050 PET/CT scan
• Patients whose clinical care may be compromised because of the delay resulting from performance of the 18F MEL050 PET/CT scan
• Patients whose only metastatic lesion is in the Central Nervous System
• Patients with urinary incontinence or patients who cannot comfortably hold their urine for more than 90 minutes
• Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
• Patients unwilling or unable to comply with protocol and patients with a history of non compliance or inability to grant informed consent.