Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04904120
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent
2. Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment
3. Blood counts and metabolic results within protocol limits within 14 days prior to enrollment
4. Ability to lie flat and still for a minimum of two hours for imaging
5. 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
6. Documented life expectancy of at least 3 months
Exclusion Criteria:
1. Active secondary malignancy
2. Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable
3. Pregnancy or breast feeding a child
4. Uncontrolled infection
5. Treatment with another investigational drug within 30 days prior to enrollment date
6. Any treatment with BRAF inhibitors since the baseline FDG-PET scan or plans for such treatment during the study
7. Kidney function not within protocol limits
8. BMI\>40 kg/m2
9. History of a condition resulting in anaphylaxis or angioedema
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT04904120
Study Brief:
Protocol Section:
NCT04904120