Analyzing PET scans and blood samples in melanoma patients receiving immunotherapy
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
This study is testing if early PET scans and blood tests can help predict how well immunotherapy works for people with advanced melanoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | ipilimumab, nivolumab, pembrolizumab, immunotherapy |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06199713 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the correlation between early FDG PET/CT imaging and circulating tumor DNA (ctDNA) levels in patients with advanced melanoma undergoing immune checkpoint inhibitor (ICI) therapy. By enrolling 24 participants, the study will assess how these imaging and blood tests can predict patient responses to treatment, potential side effects, and overall survival outcomes. The research will focus on data collected within 3-4 weeks of starting ICI therapy, providing insights into the effectiveness of these assessments in managing melanoma.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced stage III or IV melanoma who are scheduled to receive ICI therapy.
Not a fit: Patients who are unable to receive ICI therapy or those currently using investigational drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which melanoma patients are likely to benefit from immunotherapy and predict potential side effects.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in correlating imaging and ctDNA levels with treatment outcomes in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Hospitals and Clinics (UWHC) — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Vincent Ma, MD — University of Wisconsin, Madison
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.