Imaging advanced lung cancer patients receiving immunotherapy
Imaging of T-cell Activation With [18F]F-araG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy
This study is testing a new imaging method to see how well immunotherapy works for people with advanced lung cancer by tracking changes in their immune response during treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CellSight Technologies, Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06107374 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the immunological response in patients with advanced non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1 directed therapy using [18F]-FARAG PET imaging. Participants will undergo PET/CT scans before and during treatment to quantify changes in PET signal and correlate these changes with clinical outcomes over a 12-month follow-up period. The study aims to provide insights into the effectiveness of immunotherapy by utilizing a novel imaging agent that targets activated T cells, offering a noninvasive method to assess immune responses.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed advanced NSCLC who are planning to undergo immunotherapy.
Not a fit: Patients with serious comorbidities, pregnant or nursing women, and those with severe claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to monitor and predict responses to immunotherapy in lung cancer patients, leading to more personalized treatment approaches.
How similar studies have performed: While the use of PET imaging in immunotherapy is an emerging field, this specific approach using [18F]-FARAG is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease. 2. Measurable disease. 3. ECOG performance status of 0, 1 or 2. 4. Subjects are willing to be followed at the University of Iowa. Exclusion Criteria: 1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives. 2. Pregnant women or nursing mothers. 3. Patients with severe claustrophobia.
Where this trial is running
Iowa City, Iowa
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Muhammad Furqan, M.D. — Holden Comprehensive Cancer Center
- Study coordinator: Amy Mundisev
- Email: amy-mundisev@uiowa.edu
- Phone: 319-356-1445
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.