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.
Additional locations may be listed on ClinicalTrials.gov for NCT06084806.
See trial information on ClinicalTrials.gov for a list of participating sites.
Checkpoint inhibitor therapy has led to impressive clinical successes, providing
objective and durable responses in patients with advanced cancers that previously had
very few treatment options. Unfortunately, immunotherapy works only in a relatively small
fraction of patients with solid tumors.
The current standard of care anatomic imaging adequately assessed treatment efficacy in
the pre-immunotherapy era, when tumor volume burden directly correlated with clinical
outcomes. However, anatomic imaging is found to be limited due to the cellular and
molecular nature of early responses to immunotherapy. PET imaging is a sensitive
technique that uses radiolabeled agents to visualize the distribution of specific
molecular targets in the body. Based on its ability to pinpoint molecular activity, PET
imaging agents that target key players of the immune response could offer a powerful
noninvasive tool for evaluation of complex immunologic processes within the body.
[18F]F-AraG was developed as an agent for imaging activated T cells (Namavari et al.,
2011)). [18F]F-AraG is a 18F-labeled analog of 9-b-D-Arabinofuranosylguanine a compound
that has shown selective accumulation in T cells (Eriksson, et al., 1994) and whose
prodrug, nelarabine, is FDA-approved for treatment of patients with T cell acute
lymphoblastic leukemia and T cell lymphoblastic lymphoma. [18F]F-AraG is independent of
the type of immunotherapy regimen being administered adoptive cell therapy, checkpoint
inhibitors, cancer vaccines or a combination of immunotherapy and conventional medicines.
In vivo, real time imaging of activated T cells in solid tumors before and at a timepoint
during and after CkIT therapy can help understand the effects of checkpoint blockade
therapy. Repeatability, as an estimate of the magnitude of change that distinguishes
normal physiologic and measurement variability from true biologic change, is important to
interpreting changes encountered on PET scans in the response-to-treatment setting.
This study will establish test-retest variability of [18F]F-AraG uptake in tumors
(primary and metastatic sites) and lymphoid tissue in NSCLC patients prior to start of
therapy. The results lead to a better understanding of the parameters affecting signal
quantitation.
Lead OrganizationCellSight Technologies, Inc.
Principal InvestigatorMuhammad Furqan
