Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06107374

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

Led by CellSight Technologies, Inc. · Updated on 2024-10-24

20

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Serious comorbidities that could compromise protocol objectives as judged by investigator/sponsor.
  • Pregnant women or nursing mothers.
  • Patients with severe claustrophobia.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52246

Actively Recruiting

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Research Team

A

Amy Mundisev

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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