Biodistribution and Kinetics of 18F-AraG in Non-Small Cell Lung Cancer

NCT04052412 | Unknown Phase 1 FDA Drug

• 1 other identifier: 4513
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Biodistribution of 18F-AraG

  Assessment of the distribution of 18F-AraG in patients with non-small cell lung cancer using activity concentration

  Up to 90 minutes post injection of 18F-AraG

• Kinetics of 18F-AraG

  Assessment of the rate of uptake using activity concentration of 18F-AraG in regions found to have significant AraG uptake

  Up to 90 minutes post injection of 18F-AraG

Secondary Outcomes (1)

• Assessment of biodistribution and kinetics differences between study arms

  6 months

Study Arms (2)

NSCLC with Immunotherapy without radiation

EXPERIMENTAL

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

Drug: 18F-AraG

NSCLC with Immunotherapy with radiation

EXPERIMENTAL

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

Drug: 18F-AraG

Interventions

18F-AraG DRUG

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.

NSCLC with Immunotherapy with radiation; NSCLC with Immunotherapy without radiation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead
• CellSight Technologies, Inc.: collaborator

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Related Publications (4)

• Levi J, Lam T, Goth SR, Yaghoubi S, Bates J, Ren G, Jivan S, Huynh TL, Blecha JE, Khattri R, Schmidt KF, Jennings D, VanBrocklin H. Imaging of Activated T Cells as an Early Predictor of Immune Response to Anti-PD-1 Therapy. Cancer Res. 2019 Jul 1;79(13):3455-3465. doi: 10.1158/0008-5472.CAN-19-0267. Epub 2019 May 7.

  PMID: 31064845 BACKGROUND

• Franc BL, Goth S, MacKenzie J, Li X, Blecha J, Lam T, Jivan S, Hawkins RA, VanBrocklin H. In Vivo PET Imaging of the Activated Immune Environment in a Small Animal Model of Inflammatory Arthritis. Mol Imaging. 2017 Jan 1;16:1536012117712638. doi: 10.1177/1536012117712638.

  PMID: 28625080 BACKGROUND

• Ronald JA, Kim BS, Gowrishankar G, Namavari M, Alam IS, D'Souza A, Nishikii H, Chuang HY, Ilovich O, Lin CF, Reeves R, Shuhendler A, Hoehne A, Chan CT, Baker J, Yaghoubi SS, VanBrocklin HF, Hawkins R, Franc BL, Jivan S, Slater JB, Verdin EF, Gao KT, Benjamin J, Negrin R, Gambhir SS. A PET Imaging Strategy to Visualize Activated T Cells in Acute Graft-versus-Host Disease Elicited by Allogenic Hematopoietic Cell Transplant. Cancer Res. 2017 Jun 1;77(11):2893-2902. doi: 10.1158/0008-5472.CAN-16-2953.

  PMID: 28572504 BACKGROUND

• Namavari M, Chang YF, Kusler B, Yaghoubi S, Mitchell BS, Gambhir SS. Synthesis of 2'-deoxy-2'-[18F]fluoro-9-beta-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET. Mol Imaging Biol. 2011 Oct;13(5):812-8. doi: 10.1007/s11307-010-0414-x.

  PMID: 20838911 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dustin Osborne, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin R Osborne, PHD

CONTACT

8653058264; DOSBORNE@UTMCK.EDU

Melissa Weaver

CONTACT

8653056181; mweaver@utmck.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Physicians responsible for care are blinded to detailed study results to prevent any potential alterations to patient treatment. All treatment decisions are based on standard of care without regard for the biodistribution data collected from this study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a biodistribution and kinetics study looking at the uptake of 18F-AraG in non-small cell lung cancer patients in 3 different arms as follows: 1. Non-small cell lung cancer undergoing immunotherapy without radiation therapy 2. Non-small cell lung cancer undergoing immunotherapy with adjuvant radiation therapy

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 9, 2019
• Study Start: July 16, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)