Recruiting
Phase 1

18F-AraG

Sponsor:

University of Tennessee

Code:

NCT04052412

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

18F-AraG

Study Details

Brief summary:

This study is to assess the biodistribution and kinetics of a novel T-cell imaging agent in non-small cell lung cancer patients undergoing immunotherapy with and without adjuvant radiation therapy. This study is assessing the change in kinetics that occurs in this patient population to better understand the distribution of this compound in patient disease circumstances.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT04052412

Start date

Jul 16, 2019

Status verified date

May, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • This study is open to all adult subjects with histological confirmation of NSCLC enrolled in the parent protocol.
  • Age 21 years of age or greater
  • ECOG performance status of 0, 1, 2 or 3 at the time of enrollment.
  • Patient with life expectancy ≥ 24 weeks from the time of screening to the study
  • Ability to give informed consent

Exclusion Criteria:

  • Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed).
  • Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.
  • Pregnancy
  • Breast Feeding an infant
  • Unable to tolerate the expected radiation therapy prescription

Study Design

Enrollment

2 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: NSCLC with Immunotherapy without radiation

The biodistribution and kinetics of the 18F-AraG compound will be assessed in non-small cell lung cancer patients undergoing immunotherapy without adjuvant radiation therapy

experimental: NSCLC with Immunotherapy with radiation

The biodistribution and kinetics of the 18F-AraG compound will be assessed in non-small cell lung cancer patients undergoing immunotherapy with adjuvant radiation therapy

Interventions

18F-AraG

All arms of the study will receive an injection of 18F-AraG while on the PET imaging system. Following a 6 minute scan over the heart to acquire input function data, the patient will undergo a 1 hour multi-pass whole-body dynamic PET/CT acquisition to gather whole-body biodistribution data.

Primary outcome measure

  • Biodistribution of 18F-AraG [ Time Frame: Up to 90 minutes post injection of 18F-AraG ]
  • Kinetics of 18F-AraG [ Time Frame: Up to 90 minutes post injection of 18F-AraG ]

Central Contacts and Locations

Central contacts

Dustin R Osborne, PHD

8653058264DOSBORNE@UTMCK.EDU

Melissa Weaver

8653056181mweaver@utmck.edu

Locations

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Melissa Weaver

865-305-6181mweaver@utmck.edu

Shelley Acuff

8653056312sacuff@utmck.edu

Principal Investigator:

Dustin Osborne, PhD

More Information

Sponsor

University of Tennessee

Last update posted

May 13, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Tennessee on 2022-05-13.