NCT06199713Recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 27 Dec 2023
- Start date
- 30 Jan 2024
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Melanoma
- NCT number
- NCT06199713
What you commit to
- Study type: Observational
- Planned participants: 24
- From 30 Jan 2024 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not able to receive treatment with ICI therapy
- Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Hospitals and Clinics (UWHC) Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.