Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG
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.
Checked against the public recordLast updated Oct 24, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- CellSight Technologies, Inc.
- Interventions being studied
- Drug: [18F]F-AraG
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Iowa Hospitals and ClinicsIowa City, Iowa
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 24, 2024. Always confirm current availability with the study team.