Melanoma Clinical Trial

Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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
Kidney function not within protocol limits
BMI>40 kg/m2
History of a condition resulting in anaphylaxis or angioedema

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT04904120

Recruitment Status:

Recruiting

Sponsor:

Viewpoint Molecular Targeting

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There is 1 Location for this study

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Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Kelly T Dunagan, RN
Contact
507-422-6696
[email protected]
Kera L Delaney
Contact
507-422-6565
[email protected]
Geoffrey B Johnson, MD, PhD
Principal Investigator
Carrie B Hruska, PhD
Sub-Investigator
Bradley J Kemp, PhD
Sub-Investigator
Mukesh K Pandey, PhD
Sub-Investigator
Matthew S Block, MD, PhD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

10

Study ID:

NCT04904120

Recruitment Status:

Recruiting

Sponsor:


Viewpoint Molecular Targeting

How clear is this clinincal trial information?

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