NCT04904120

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Perspective Therapeutics · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a first-in-human study evaluating the suitability of \[203Pb\]VMT01 for SPECT/CT imaging and \[68Ga\]VMT02 for PET/CT imaging of MC1R-expressing metastatic melanoma. Study results will provide foundational data to develop imaging and dosing for future therapeutic trials of \[212Pb\]VMT01 for the treatment of metastatic melanoma. The study will be a cross-over study with the participants serving as their own comparator. Participants with positive FDG-PET scans for stage IV (or inoperable stage III) metastatic melanoma will undergo SPECT/CT scans utilizing \[203Pb\]VMT01 followed a few weeks later by PET/CT scans utilizing \[68Ga\]VMT02, or vice versa. The order of the imaging agents will be randomly assigned.

Conditions

• Melanoma (Skin)
• Melanoma Stage IV
• Melanoma, Uveal
• Melanoma, Mucosal

Interventions

Type	Name	Description
DRUG	[203Pb]VMT01	Diagnostic imaging radiopharmaceutical; by intravenous infusion
DRUG	[68Ga]VMT02	Diagnostic imaging radiopharmaceutical; by intravenous infusion

Timeline

• Start date: 2021-03-05
• Primary completion: 2022-09-20
• Completion: 2022-09-20
• First posted: 2021-05-27
• Last updated: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study