Status:
COMPLETED
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
Lead Sponsor:
Perspective Therapeutics
Collaborating Sponsors:
Mayo Clinic
Conditions:
Melanoma (Skin)
Melanoma Stage IV
Eligibility:
All Genders
18-89 years
Phase:
PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04904120
Start Date
March 5 2021
End Date
September 20 2022
Last Update
November 7 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905