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

RecruitingPhase 2Ages 18 Years - anyAllCellSight Technologies, Inc.
NCT06107374 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease. 2. Measurable disease. 3. ECOG performance status of 0, 1 or 2. 4. Subjects are willing to be followed at the University of Iowa. Exclusion Criteria: 1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives. 2. Pregnant women or nursing mothers. 3. Patients with severe claustrophobia.
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What it tests

  • [18F]F-AraG
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Where

1 site
University of Iowa Hospitals and Clinics
Iowa City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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