Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
Correlation Between Early Interval 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (PET/CT) and Circulating Tumor DNA (ctDNA) in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors
University of Wisconsin, Madison
24 participants
Jan 30, 2024
OBSERVATIONAL
Conditions
Summary
The purpose of this research study is to determine if analysis of PET/CT scans and testing of blood samples in people with melanoma that has spread in their body can help researchers determine which patients are more or less likely to respond to immunotherapy and are more or less likely to have side effects. 24 participants will be enrolled and be on study until approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.
Eligibility
Inclusion Criteria6
- Willing to provide informed consent.
- Must have an advanced stage III or stage IV melanoma diagnosis for which treatment with ipilimumab, nivolumab, and/or pembrolizumab, either alone or in combination with other ICI therapy, is planned.
- Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard of care laboratory testing routinely obtained for treatment with ICI therapy.
- Individuals at least 18 years of age.
- Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study.
- Willing to comply with all study procedures and be available for the duration of the study.
Exclusion Criteria4
- Not able to receive treatment with ICI therapy
- Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
- Women who are pregnant, lactating, or planning on becoming pregnant during the study.
- Not suitable for study participation due to other reasons at the discretion of the investigators.
Interventions
research scan 3-4 weeks after start of immunotherapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06199713