Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
Part of paid clinical trials in Madison, Wisconsin.
- Sponsor
- University of Wisconsin, Madison
- Study ID
- NCT06199713
- Status
- Recruiting
Conditions
- Melanoma
- Melanoma Stage III
- Melanoma Stage IV
- Unresectable Melanoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography — DIAGNOSTIC_TESTresearch scan 3-4 weeks after start of immunotherapy
Study Details
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.
Key Dates
- Start date
- Jan 30, 2024
- Status verified
- Jan 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2029
Study Design
- Enrollment
- 24 participants (estimated)
Arms
- Arm: Advanced Melanoma Patients with Immune Checkpoint Inhibitors
Primary Outcome Measure
Change in ctDNA level from baseline to 3-4 week after the start of therapy [ Time Frame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study) ]
Central Contacts
- Cancer Connect800-622-8922
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Wisconsin Hospitals and Clinics (UWHC) | Madison | Wisconsin | 53792 | Steve Cho, MD (PRINCIPAL_INVESTIGATOR) Vincent Ma, MD (PRINCIPAL_INVESTIGATOR) |
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