NCT04678440

[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients

A Pilot Study of [18F]F-AraG Pharmacokinetics in Tumors and Non-Malignant Tissue Using Dynamic Total Body PET Imaging in Healthy Subjects and in Patients With Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this pilot study, healthy volunteers and patients with Non-Small Cell Lung Cancer will undergo \[18F\]F-AraG dynamic imaging on the uEXPLORER total body Positron Emission Tomography/Computerized Tomography scanner to obtain preliminary data regarding pharmacokinetics and early biodistribution images.

Detailed description

\[18F\]F-AraG, a fluorine-18 labeled analog of an FDA approved drug (Nelarabine) is a new imaging tracer targeted at imaging activated T-cells. Given that immunotherapeutic strategies, in particular immune checkpoint antibodies, focus on the generation of T-cell-based antitumor immunity, uptake of \[18F\]F-AraG within the tumor is hypothesized to correlate with T-cell mediated immune response seen in the biopsy samples of cancer patients treated with immune checkpoint blockade. Correlation of pre- and post-treatment intratumoral immune infiltration by means of PET imaging will guide the development of future clinical trials investigating the role of \[18F\]F-AraG in the monitoring of anti-tumor immune responses. Therefore, proper quantification of \[18F\]F-AraG uptake in tumor lesions, and understanding its relation with physiologic uptake in background tissues is important. Note: checkpoint therapy in this study is standard-of-care and is not under investigation. Available PET/CT scanners can obtain dynamic images only on a portion of the body as large as their axial field of view, generally anywhere between 15-30 cm. The 194 cm long uEXPLORER total-body PET scanner is the world's first device to offer the ability to tomographically image all parts of the body simultaneously. Thus, the uEXPLORER PET/CT (now commercially available and with FDA 510(k) clearance) is the only scanner in the world capable of acquiring total-body dynamic images. In this pilot study, 2-4 healthy volunteers will undergo \[18F\]F-AraG dynamic imaging on the uEXPLORER total body PET/CT scanner to obtain preliminary data regarding pharmacokinetics and early biodistribution images. In addition, 2-4 patients with NSCLC and planned for standard-of-care PD-1/PD-L1 immunotherapy will undergo \[18F\]F-AraG dynamic imaging similarly on the uEXPLORER total body PET/CT scanner to obtain data regarding pharmacokinetics of the tracer in tumor lesions in the context of normal tissue uptake. An optional second similar scan will be performed 7-14 days after the first dose of immunotherapy to explore and document any treatment related changes in \[18F\]F-AraG uptake and kinetics. The study and data collected will be important to recommend an ideal time to acquire a whole body static scan using conventional and widely available PET/CT scanners for adequate tumor to background contrast and quantification, which in turn, will be essential for further clinical development of \[18F\]F-AraG to aid the monitoring of anti tumor immune responses.

Conditions

• Lung Cancer, Nonsmall Cell

Interventions

Type	Name	Description
DRUG	[18F]F-AraG Imaging	Total body PET imaging using \[18F\]F-AraG

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2020-12-22
• Last updated: 2025-07-02
• Results posted: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study