Of 18F MEL050 Using PET/CT in Metastatic Melanoma

Early Phase 1

• Conditions: Metastatic Melanoma
• Interventions: Radiation: 18F MEL050

• Registration Number: NCT01620749
• Lead Sponsor: Cooperative Research Centre for Biomedical Imaging Development

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2012-03
• Study First Submitted: 2012-05-27
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-14
• Last Update Submitted: 2012-06-14
• Study First Posted: 2012-06-15
• Last Update Posted: 2012-06-15
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEL050	18F MEL050	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia