NCT05701176

A Clinical Imaging Study of the Changes in [18F]F-AraG Uptake Following Anti-PD-1 Therapy in Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

\[18F\]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the SHARP trial is to investigate changes in \[18F\]F-AraG uptake following Anti-PD-1 therapy in patients with non-small cell lung cancer (NSCLC).

Detailed description

The efficacy of immunotherapy and patient selection for combinatorial immunotherapy strategies would greatly improve if the tumor microenvironment (TME) could be characterized more accurately. Positron emission tomography (PET) using tracers that target immune cell subsets may provide a non-invasive means to immune profile the TME. Imaging T-cells can help in identifying 'hot' tumors, or parts of the tumor mass that have high concentrations of tumor infiltrating T-cells and also provide information on its activation. A promising tracer to image activated T-cells is \[18F\]F-AraG. Based on the hypothesis that \[18F\]F-AraG will accumulate in activated T-cells, it is expected that \[18F\]F-AraG and PET will enable to identify tumors and tumor areas with high concentrations of tumor infiltrating activated T-cells on pathological assessment. In the SHARP trial, participants receive 3 longitudinal \[18F\]F-AraG PET scans during anti-PD-1 immunotherapy to explore the changes in uptake of \[18F\]F-AraG during the treatment.

Conditions

• Advanced Stage Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[18F]F-AraG PET scan	\[18F\]F-AraG PET scans are performed to assess the accumulation of activated T-cells in the tumour and healthy tissue.

Timeline

• Start date: 2022-11-03
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2023-01-27
• Last updated: 2025-03-28

Locations

1 site across 1 country: Netherlands