Clinical Trial

Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG

Recruiting Phase 2
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Record status
This record was last updated October 24, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-10-24.
Status change: Not Yet Recruiting → Recruiting 2024-10-22
Trial Details
NCT Number NCT06107374
Lead Sponsor CellSight Technologies, Inc.
Conditions Advanced Non Small Cell Lung Cancer
Enrollment 20 participants
Start Date 2023-11-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-24