Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04904120 | Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy | PHASE1 | COMPLETED | 7 | — | — | Mar 5, 2021 | Sep 20, 2022 | Nov 7, 2023 | 1 | United States |
Adverse Events (AEs) will be assessed for severity according to CTCAE v5.0 and for relatedness to each of the investigative imaging agents (\[203Pb\]VMT01 and \[68Ga\]VMT02). Assessments attributed as possibly, probably, or definitely related to the imaging agent will be considered related.
Biodistribution will be calculated by utilizing PET/CT scans.
Biodistribution will be calculated by utilizing SPECT/CT scans.
Cmax will be determined by blood sampling and direct radioactivity measurements.
AUC will be determined by blood sampling and direct radioactivity measurements.
Renal excretion will be determined by urine sampling and direct radioactivity measurements.
Dosimetry will be modeled by utilizing the SPECT/CT scans.
| Arm | Type | Description |
|---|---|---|
| [203Pb]VMT01 first | ACTIVE_COMPARATOR | Participants randomized to this arm will receive imaging agent \[203Pb\]VMT01 and undergo SPECT/CT imaging first. Later, participants in this arm will receive \[68Ga\]VMT02 and undergo PET/CT imaging. |
| [68Ga]VMT02 first | ACTIVE_COMPARATOR | Participants randomized to this arm will receive imaging agent \[68Ga\]VMT02 and undergo PET/CT imaging first. Later, participants in this arm will receive \[203Pb\]VMT01 and undergo SPECT/CT imaging. |
| Name | Type | Description |
|---|---|---|
| [203Pb]VMT01 | DRUG | Diagnostic imaging radiopharmaceutical; by intravenous infusion |
| [68Ga]VMT02 | DRUG | Diagnostic imaging radiopharmaceutical; by intravenous infusion |
Inclusion Criteria: 1. Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent 2. Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment 3. Blood counts and metabolic results within protocol limits within 14 days prior to enrollm...