This trial is active, not recruiting.

Condition metastatic melanoma
Treatment 18f mel050
Phase phase 0
Sponsor Cooperative Research Centre for Biomedical Imaging Development
Start date June 2010
End date March 2012
Trial size 12 participants
Trial identifier NCT01620749, 10/11


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
18f mel050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

Primary Outcomes

Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
time frame: Up to 28 days following 18F MEL050 administration (+/- 7 days)

Secondary Outcomes

Percentage of injected 18F MEL050 dose in organs of interest.
time frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
time frame: 60, 120 and 180 minutes post 18F MEL050 administration.
Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.
time frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Grant McArthur
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Cooperative Research Centre for Biomedical Imaging Development.