Test-retest Evaluation of [18F]F-AraG PET
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellSight Technologies, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
Pregnant women or nursing mothers.
Patients with severe claustrophobia.
Trial design
Treatments tested in this trial
- [18F]F-ARAG PET
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
CellSight Technologies, Inc.
Lead sponsor
University of Iowa
Collaborator
Source ClinicalTrials.gov