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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
CellSight Technologies, Inc.
Study ID
NCT06107374
Phase
PHASE2
Status
Recruiting

Conditions

  • Advanced Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]F-AraG — DRUG
    Two PET scans

Study Details

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 Dates

Start date
Nov 1, 2023
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy

Primary Outcome Measure

[18F]F-AraG Quantification [ Time Frame: One Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals and ClinicsIowa CityIowa52246
Amy Mundisev
319-356-1445

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