Clinical trial · Interventional
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
A Phase 1 Cross-over Biodistribution Study of [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) Imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) Imaging of Stage IV Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma, Mucosal | Mucosal Melanoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Melanoma Stage IV | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma, Uveal | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [203Pb]VMT01 | Drug | — | UNRESOLVED |
| [68Ga]VMT02 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- [203Pb]VMT01 first
- description
- 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.
- interventionNames
- Drug: [203Pb]VMT01
- Drug: [68Ga]VMT02
- type
- ACTIVE_COMPARATOR
- label
- [68Ga]VMT02 first
- description
- 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.
- interventionNames
- Drug: [203Pb]VMT01
- Drug: [68Ga]VMT02
Primary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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 enrollment 4. Ability to lie flat and still for a minimum of two hours for imaging 5. 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 6. Documented life expectancy of at least 3 months Exclusion Criteria: 1. Active secondary malignancy 2. Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable 3. Pregnancy or breast feeding a child 4. Uncontrolled infection 5. Treatment with another investigational drug within 30 days prior to enrollment date 6. Any treatment with BRAF inhibitors since the baseline FDG-PET scan or plans for such treatment during the study 7. Kidney function not within protocol limits 8. BMI\>40 kg/m2 9. History of a condition resulting in anaphylaxis or angioedema
References
Publications (0)
Data not yet available