Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy (NCT04904120) | Clinical Trial Compass
CompletedPhase 1
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
United States7 participantsStarted 2021-03-05
Plain-language summary
The study hypothesis is that new imaging agents \[203Pb\]VMT01 and \[68Ga\]VMT02 can be safely used in humans without independent biological effect and can be used to image melanoma tumors expressing the melanocortin sub-type 1 receptor (MC1R) by SPECT/CT and PET/CT imaging modalities respectively.
Who can participate
Age range18 Years – 89 Years
SexALL
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Inclusion criteria
✓. Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent
✓. Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment
✓. Blood counts and metabolic results within protocol limits within 14 days prior to enrollment
✓. Ability to lie flat and still for a minimum of two hours for imaging
✓. Male and female participants with reproductive potential must agree to use highly effective contraception in preparation of the study, during the study, and for 4 weeks following the last dose of an investigative imaging agent
✓. Documented life expectancy of at least 3 months
Exclusion criteria
✕. Active secondary malignancy
✕. Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable
✕. Pregnancy or breast feeding a child
✕. Uncontrolled infection
✕. Treatment with another investigational drug within 30 days prior to enrollment date
✕. Any treatment with BRAF inhibitors since the baseline FDG-PET scan or plans for such treatment during the study
✕
What they're measuring
1
Number of Participants with Study Imaging Agent-Associated Adverse Events (AE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Timeframe: Visit 1 (Day 1) through Visit 5 (approximately Day 60 but could extend up to Day 108); ongoing Serious Adverse Events (SAE) will be followed for no longer than Day 65 or 30 days from the date of the SAE report (whichever is later).
2
Biodistribution of [68Ga]VMT02
Timeframe: 12 hours
3
Biodistribution of [203Pb]VMT01
Timeframe: 24 hours
4
Peak Plasma Concentration (Cmax) of [203Pb]VMT01
Timeframe: 24 hours
5
Area Under the Plasma Concentration Versus Time Curve (AUC) for [203Pb]VMT01