Recruiting

FDG PET/CT & ctDNA

Sponsor:

University of Wisconsin, Madison

Code:

NCT06199713

Conditions

Melanoma

Melanoma Stage III

Melanoma Stage IV

Unresectable Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Study Details

Brief 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.

Conditions

Melanoma

Melanoma Stage III

Melanoma Stage IV

Unresectable Melanoma

Study ID

NCT06199713

Start date

Jan 30, 2024

Status verified date

Jan, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Not able to receive treatment with ICI therapy
  • Use of investigational drugs, biologics, or devices within 30 days prior to enrollment.
  • 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.

Study Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

Advanced Melanoma Patients with Immune Checkpoint Inhibitors

Interventions

18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

research scan 3-4 weeks after start of immunotherapy

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) ]
  • Change in 18F-FDG PET/CT response 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) ]
  • Correlation between ctDNA level change and 18F-FDG PET/CT response 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) ]
  • Diagnostic Accuracy of ctDNA level trend and PET/CT imaging for predicting growth inhibition as measured by Area under the Curve [ Time Frame: baseline to 3-4 weeks after start of therapy (up to 5 weeks on study) ]

Central Contacts and Locations

Central contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

University of Wisconsin Hospitals and Clinics (UWHC)

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Steve Cho, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • circulating tumor DNA
  • FDG
  • ICI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-01-20.