Metastatic Melanoma
Conditions
Keywords
melanoma metastatic diagnosis
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.
Interventions
RADIATION18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
Sponsors
Cooperative Research Centre for Biomedical Imaging Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Australia
Outcome results
None listed