Analyzing PET scans and blood samples in melanoma patients receiving immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.