RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Imaging of T-cell Activation With [18F]F-araG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy

Quick Facts

Study Start:2023-11-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06107374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
  2. 2. Measurable disease.
  3. 3. ECOG performance status of 0, 1 or 2.
  4. 4. Subjects are willing to be followed at the University of Iowa.
  1. 1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
  2. 2. Pregnant women or nursing mothers.
  3. 3. Patients with severe claustrophobia.

Contacts and Locations

Study Contact

Amy Mundisev
CONTACT
319-356-1445
amy-mundisev@uiowa.edu

Principal Investigator

Muhammad Furqan, M.D.
PRINCIPAL_INVESTIGATOR
Holden Comprehensive Cancer Center

Study Locations (Sites)

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52246
United States

Collaborators and Investigators

Sponsor: CellSight Technologies, Inc.

  • Muhammad Furqan, M.D., PRINCIPAL_INVESTIGATOR, Holden Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Non Small Cell Lung Cancer