Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- CellSight Technologies, Inc.
- Study ID
- NCT06107374
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Advanced Non Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- [18F]F-AraG — DRUGTwo PET scans
Study Details
This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.
Key Dates
- Start date
- Nov 1, 2023
- Status verified
- Oct 2024
- Primary completion
- Dec 31, 2025
- Completion
- Mar 31, 2026
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy
Primary Outcome Measure
[18F]F-AraG Quantification [ Time Frame: One Year ]
Central Contacts
- Amy Mundisev319-356-1445
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52246 |
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