[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients

NCT04678440 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 1630355CST-FARAG-203
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, healthy volunteers and patients with Non-Small Cell Lung Cancer will undergo \[18F\]F-AraG dynamic imaging on the uEXPLORER total body Positron Emission Tomography/Computerized Tomography scanner to obtain preliminary data regarding pharmacokinetics and early biodistribution images.

Conditions

Lung Cancer, Nonsmall Cell

Keywords

total body positron emission tomography

Outcome Measures

Primary Outcomes (3)

• Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues

  Data on \[18F\]F-AraG uptake in several tissue types will be collected from healthy subjects. This data will be presented in the form of time-activity curves (TAC) generated for each tissue type. Quantitative assessment of \[18F\]F-AraG biodistribution in healthy tissues will be reported as a function of time as mean Standard Uptake Value (SUV)

  Baseline

• Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects

  Data on \[18F\]F AraG uptake in tumor lesions and background activity in the same tissues as in Outcome 1 will be collected. This data will be similarly presented in the form of time-activity curves (TAC) generated for each tissue type, as well as for tumor lesions against their background tissues.

  Baseline and 7-14 days after first dose of PD-1/PD-L1

• Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake

  We will calculate the tumor-to-background Standardized Uptake Value Ratio (SUVR) at multiple time points. The primary aim is to identify the earliest time at which the SUVR indicates adequate tumor uptake relative to non-malignant tissue. This will guide recommendations for the ideal imaging start time for static whole-body scans.

  Baseline and 7-14 days after first dose of PD-1/PD-L1

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

Study participants will undergo a single dynamic \[18F\]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of \[18F\]F-AraG.

Drug: [18F]F-AraG Imaging

Non-Small Cell Lung Cancer Patients (NSCLC)

EXPERIMENTAL

Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the uEXPLORER total-body scanner.

Drug: [18F]F-AraG Imaging

Interventions

[18F]F-AraG Imaging DRUG

Total body PET imaging using \[18F\]F-AraG

Healthy Volunteers; Non-Small Cell Lung Cancer Patients (NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.
• Willingness and ability to comply with all protocol required procedures.
• For men and women of child-producing potential, willingness to use of effective double barrier contraceptive methods during the study, up to 1 day after the last administration of the investigational product.
• For NSCLC subjects only:
• Patients with histologically confirmed advanced, locally advanced, or localized NSCLC.
• Planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as 1) monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease; 2) As consolidation therapy following chemoradiation for locally advanced disease or 3) As induction therapy either as monotherapy or combination therapy with chemotherapy prior to planned surgical resection
• At least 1 tumor lesion \> 1 cm (cannot be only in liver) documented on CT or MRI or FDG-PET/CT (RECIST criteria 1.1; \>1.5 cm for nodal lesions) within 45 days prior to scan date.
• Per investigator's assessment and in consultation with oncologists, at least one eligible lesion must be sufficiently separated from tissues with known high \[18F\]F-AraG uptake, such as salivary glands, bladder, liver and kidneys so that quantification will be feasible.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.

You may not qualify if:

• Subjects are not eligible if they meet ANY of the following criteria:
• Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
• History of recent COVID-19 infection within the last 2 months OR history of COVID requiring hospitalization with lung injury at Investigator's discretion
• Subjects with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the scan
• Subjects receiving therapy with nucleoside analogs including but not limited to: acyclovir, valaclovir, penciclovir, famciclovir, ganciclovir, ribavirin, valganciclovir, glanciclovir
• Pregnant women or nursing mothers.
• Body weight more than 240 kg (529 pounds)
• For NSCLC subjects only:
• Prior Treatment with anti-PD-1/PD-L1 immunotherapy.
• For Healthy subjects
• No primary care physician

Sponsors & Collaborators

• University of California, Davis: lead
• CellSight Technologies, Inc.: collaborator

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Location

Related Links

• Learn more or sign up for the study here!

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

Results Point of Contact

• Title: Simon Cherry
• Organization: University of California Davis

srcherry@ucdavis.edu

(530) 754-9419

Study Officials

• Simon R Cherry, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Healthy volunteers and patients with non-small cell lung cancer will undergo identical total-body PET scans. Lung cancer patients will undergo an additional PET scans after starting treatment.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: March 31, 2021
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: July 2, 2025
• Results First Posted: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)