RecruitingNCT06199713

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

Sponsor

University of Wisconsin, Madison

Enrollment

24 participants

Start Date

Jan 30, 2024

Study Type

OBSERVATIONAL

Conditions

Melanoma Unresectable Melanoma Melanoma Stage IV Melanoma Stage III

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines two methods of monitoring advanced melanoma during immunotherapy treatment: a blood test that detects cancer DNA fragments (ctDNA) and PET/CT imaging. The goal is to see if tracking ctDNA alongside scans can predict which patients are responding to treatment earlier and more accurately. **You may be eligible if...** - You are 18 years or older - You have Stage III or Stage IV melanoma - You are planning to start treatment with checkpoint immunotherapy drugs (ipilimumab, nivolumab, or pembrolizumab) - You agree to ctDNA blood monitoring (Signatera test) alongside standard blood tests - Women of childbearing age must use contraception **You may NOT be eligible if...** - You have a different stage of melanoma - You are not planning to receive checkpoint immunotherapy - You decline ctDNA monitoring Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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