Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG

Recruiting now · Phase 2

Conditions studied: Advanced Non Small Cell Lung Cancer

In brief

This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. 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.

Key facts

Study ID

NCT06107374

Run by

CellSight Technologies, Inc.

People needed

20

Starts

2023-11-01

Expected to finish

2026-03-31

Last updated by the study team

2024-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
• Measurable disease.
• ECOG performance status of 0, 1 or 2.
• Subjects are willing to be followed at the University of Iowa.

You may not qualify if…

• 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

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

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