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_TEST
    research 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Hospitals and Clinics (UWHC)MadisonWisconsin53792
Steve Cho, MD (PRINCIPAL_INVESTIGATOR)
Vincent Ma, MD (PRINCIPAL_INVESTIGATOR)

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