Test-retest Evaluation of [18F]F-AraG PET
Recruiting · NCT06084806 · Interventional (participants receive a specific treatment) · Lead sponsor: CellSight Technologies, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This pilot study aims to evaluate the test-retest variability of \[18F\]F-AraG-PET imaging in patients with advanced NSCLC tumors. The main objectives of the study are to quantify the uptake of \[18F\]F-AraG in tumors and lymphoid tissue in two consecutive scans spaced not longer than 7 days apart from each other to estimate the magnitude of physiologic and measurement variability. To explore these objectives, eligible subjects will undergo two \[18F\]F-AraG PET/CT scans within 7 days of each other prior to receiving treatment. 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.
Who can take part
Inclusion criteria
- Patients (\>18 years old) with a histologically confirmed NSCLC and a candidate to receive immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
- Measurable disease.
- ECOG performance status of 0, 1 or 2.
Exclusion criteria
- Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
- Pregnant women or nursing mothers.
- Patients with severe claustrophobia.
Where it is running
1 location listed across 1 US state.
- University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States