TheranosticTrials.org
Perspective Therapeutics

Clinical Trial · NCT04904120

Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

Overview

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.

Sponsor

Perspective Therapeutics

Phase

Phase 1

Contacts

Geoffrey B Johnson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Frances L Johnson, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04904120

Drug / Compound

VMT02

Isotope(s):
Target(s):
  • MC1R
Ligand Class: Peptides
Chelator: DOTA
Linker: PEG2

VMT01

Isotope(s):
Target(s):
  • MC1R
Ligand Class: Peptides
Chelator: DOTA
Linker: PEG2

Eligibility

Inclusion

  • 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
  • Ability to lie flat and still for a minimum of two hours for imaging
  • Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent
  • Documented life expectancy of at least 3 months
  • Blood counts and metabolic results within protocol limits within 14 days prior to enrollment
  • Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment

Exclusion

  • Kidney function not within protocol limits
  • History of a condition resulting in anaphylaxis or angioedema
  • BMI\>40 kg/m2
  • Pregnancy or breast feeding a child
  • Any treatment with BRAF inhibitors since the baseline FDG-PET scan or plans for such treatment during the study
  • Active secondary malignancy
  • Treatment with another investigational drug within 30 days prior to enrollment date
  • Uncontrolled infection
  • Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable

Patient Education

Patient education not yet provided.

Publications

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Locations

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