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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04904120.
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.
Lead OrganizationPerspective Therapeutics