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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Of 18F MEL050 Using PET/CT in Metastatic Melanoma
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Study type
Description of intervention(s) / exposure
Treatment: Other - 18F MEL050

Experimental: MEL050 -

Treatment: Other: 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
Timepoint [1] 0 0
Up to 28 days following 18F MEL050 administration (+/- 7 days)
Secondary outcome [1] 0 0
Percentage of injected 18F MEL050 dose in organs of interest.
Timepoint [1] 0 0
10, 30, 60 and 120 minutes post 18F MEL050 administration
Secondary outcome [2] 0 0
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Timepoint [2] 0 0
60, 120 and 180 minutes post 18F MEL050 administration.
Secondary outcome [3] 0 0
Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.
Timepoint [3] 0 0
10, 30, 60 and 120 minutes post 18F MEL050 administration

Key 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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 0
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Cooperative Research Centre for Biomedical Imaging Development

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Grant McArthur
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see