Actively Recruiting
Correlation Between Early Interval 18F-Fluorodeoxyglucose PET/CT and Circulating Tumor DNA in Advanced Melanoma Patients Treated With Immune Checkpoint Inhibitors
Led by University of Wisconsin, Madison · Updated on 2026-01-20
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether early analysis of PET/CT scans and blood tests can help predict how people with advanced melanoma respond to immune checkpoint inhibitor (ICI) therapy. This observational study focuses on patients with stage III or IV melanoma and aims to understand the relationship between imaging results, circulating tumor DNA (ctDNA) levels, treatment response, side effects, and survival outcomes. The study is led by the University of Wisconsin, Madison, and enrolls 24 participants. Participants will undergo baseline and early interval 18F-FDG PET/CT scans approximately 3 to 4 weeks after starting ICI therapy, such as ipilimumab, nivolumab, or pembrolizumab. Blood samples will be tested for ctDNA levels at the same intervals to observe changes during treatment. This study does not involve administering treatments but observes participants receiving standard ICI care. The early imaging and ctDNA tests aim to correlate with treatment response and side effect development. During the study, participants will be followed until about 4 weeks after their first ICI dose for initial measurements and may be monitored up to 3 years for progression-free and overall survival outcomes. Researchers will collect data from scans, blood tests, clinical assessments, and standard laboratory monitoring. The study evaluates changes in ctDNA and PET/CT findings to predict treatment effectiveness and immune-related side effects, with safety and survival tracked throughout the follow-up period.
CONDITIONS
Brief Title
Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide informed consent
- Diagnosed with advanced stage III or stage IV melanoma
- Planned treatment with ipilimumab, nivolumab, and/or pembrolizumab, alone or with other immune checkpoint inhibitors
- Planning to participate in ctDNA monitoring with standard laboratory testing
- At least 18 years old
- Women of childbearing potential agree to use effective contraception
- Willing to comply with all study procedures and available for study duration
You will not qualify if you...
- Unable to receive treatment with immune checkpoint inhibitors
- Use of investigational drugs, biologics, or devices within 30 days before enrollment
- Pregnant, lactating, or planning pregnancy during the study
- Deemed unsuitable for participation by study investigators for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks
Participants undergo baseline and early interval 18F-FDG PET/CT imaging and ctDNA blood tests to assess initial response to immune checkpoint inhibitor therapy.
2 visits (in-person) within 3 to 4 weeks after starting therapy
Duration - Up to 3 years
Participants are monitored for clinical response, immune-related adverse events, progression-free survival, and overall survival following initial assessments.
Periodic visits up to 3 years for clinical assessments and blood tests
Trial Site Locations
Total: 1 location
1
University of Wisconsin Hospitals and Clinics (UWHC)
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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