Of 18F MEL050 Using PET/CT in Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.

Official Title
-----------------
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

Conditions
-----------------
Metastatic Melanoma

Intervention / Treatment
-----------------
* Radiation: 18F MEL050


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEL050<br> | Radiation: 18F MEL050<br>* Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration. |  | Up to 28 days following 18F MEL050 administration (+/- 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of injected 18F MEL050 dose in organs of interest. |  | 10, 30, 60 and 120 minutes post 18F MEL050 administration | 
| Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration. |  | 60, 120 and 180 minutes post 18F MEL050 administration. | 
| Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose. |  | 10, 30, 60 and 120 minutes post 18F MEL050 administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma metastatic diagnosis