Lung Cancer, Nonsmall CellEarly Phase 1NCT04678440

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

A Early Phase 1 study testing [18F]F-AraG Imaging in people with Lung Cancer, Nonsmall Cell, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Lung Cancer, Nonsmall Cell
What is being tested?: [18F]F-AraG Imaging
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2021to 7 Feb 2023
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, 95816

Other trials in United States

About this study

Official title: A Pilot Study of [18F]F-AraG Pharmacokinetics in Tumors and Non-Malignant Tissue Using Dynamic Total Body PET Imaging in Healthy Subjects and in Patients With Non-Small Cell Lung Cancer (NSCLC)

Read the detailed description

[18F]F-AraG, a fluorine-18 labeled analog of an FDA approved drug (Nelarabine) is a new imaging tracer targeted at imaging activated T-cells. Given that immunotherapeutic strategies, in particular immune checkpoint antibodies, focus on the generation of T-cell-based antitumor immunity, uptake of [18F]F-AraG within the tumor is hypothesized to correlate with T-cell mediated immune response seen in the biopsy samples of cancer patients treated with immune checkpoint blockade. Correlation of pre- and post-treatment intratumoral immune infiltration by means of PET imaging will guide the development of future clinical trials investigating the role of [18F]F-AraG in the monitoring of anti-tumor immune responses. Therefore, proper quantification of [18F]F-AraG uptake in tumor lesions, and understanding its relation with physiologic uptake in background tissues is important. Note: checkpoint therapy in this study is standard-of-care and is not under investigation.

Available PET/CT scanners can obtain dynamic images only on a portion of the body as large as their axial field of view, generally anywhere between 15-30 cm. The 194 cm long uEXPLORER total-body PET scanner is the world's first device to offer the ability to tomographically image all parts of the body simultaneously. Thus, the uEXPLORER PET/CT (now commercially available and with FDA 510(k) clearance) is the only scanner in the world capable of acquiring total-body dynamic images.

In this pilot study, 2-4 healthy volunteers will undergo [18F]F-AraG dynamic imaging on the uEXPLORER total body PET/CT scanner to obtain preliminary data regarding pharmacokinetics and early biodistribution images. In addition, 2-4 patients with NSCLC and planned for standard-of-care PD-1/PD-L1 immunotherapy will undergo [18F]F-AraG dynamic imaging similarly on the uEXPLORER total body PET/CT scanner to obtain data regarding pharmacokinetics of the tracer in tumor lesions in the context of normal tissue uptake. An optional second similar scan will be performed 7-14 days after the first dose of immunotherapy to explore and document any treatment related changes in [18F]F-AraG uptake and kinetics.

The study and data collected will be important to recommend an ideal time to acquire a whole body static scan using conventional and widely available PET/CT scanners for adequate tumor to background contrast and quantification, which in turn, will be essential for further clinical development of [18F]F-AraG to aid the monitoring of anti tumor immune responses.

Conditions: Lung Cancer, Nonsmall Cell
Being tested: [18F]F-AraG Imaging
Keywords: total body positron emission tomography
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04678440
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: [18F]F-AraG Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
Measured: 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.
Measured: Baseline and 7-14 days after first dose of PD-1/PD-L1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20217 Feb 2023

First posted22 Dec 2020
Study start31 Mar 2021
Primary completion7 Feb 2023
Study completion7 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
More trials run by University of California, DavisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04678440
Sponsor's protocol ID: 1630355
Other IDs: CST-FARAG-203
Status last verified: Jun 2025
First submitted: 16 Dec 2020
Last updated: 2 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of [18F]F-AraG Pharmacokinetics in Tumors and Non-Malignant Tissue Using Dynamic Total Body PET Imaging in Healthy Subjects and in Patients With Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT04678440
Acronym / sponsor ID: 1630355
Conditions: Lung Cancer, Nonsmall Cell
Keywords: total body positron emission tomography
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Collaborators: CellSight Technologies, Inc.
Study start: 31 Mar 2021 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 22 Dec 2020 (actual)
Results: Posted 2 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Healthy Volunteers	Experimental	Drug: [18F]F-AraG ImagingStudy 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.
Non-Small Cell Lung Cancer Patients (NSCLC)	Experimental	Drug: [18F]F-AraG ImagingStudy 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.
Patients with histologically confirmed advanced, locally advanced, or localized NSCLC.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[18F]F-AraG ImagingTotal body PET imaging using [18F]F-AraG	Drug	Healthy Volunteers, Non-Small Cell Lung Cancer Patients (NSCLC)

Primary outcome

Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues
Time frame: Baseline
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)
Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects
Time frame: Baseline and 7-14 days after first dose of PD-1/PD-L1
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.
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake
Time frame: Baseline and 7-14 days after first dose of PD-1/PD-L1
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.

Results and safety

Results posted to the registry on 2 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteers	4	4
Non-Small Cell Lung Cancer Patients (NSCLC)	1	1

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

Time frame: Baseline. Mean (Standard Deviation). Unit: SUV

Measure	Healthy Volunteers n = 4
Blood Pool	0.31 (0.01)
Myocardium	4.36 (0.27)
Brain	0.04 (0.01)
Kidney	32.88 (5.42)
Liver	16.05 (2.03)
Spleen	3.46 (0.41)
Muscle	1.05 (0.26)
Lungs	0.67 (0.12)

Population analysed: This outcome measure is only measured in the healthy subjects.

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

Time frame: Baseline and 7-14 days after first dose of PD-1/PD-L1. Mean (Standard Deviation). Unit: SUV

Measure	Non-Small Cell Lung Cancer Patients (NSCLC) n = 1
Tumor (baseline)	2.14 (0.20)
Tumor (after therapy)	2.30 (0.54)
Mediastinal Lymph Nodes (Baseline)	2.54 (0.69)
Mediastinal Lymph Nodes (after therapy)	3.15 (0.58)

Population analysed: Mean and standard deviations are reported across seven different tumor sites and four different lymph nodes.

Primary outcome: Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake

Time frame: Baseline and 7-14 days after first dose of PD-1/PD-L1. Mean (Standard Deviation). Unit: SUV to blood ratio (SUVR)

Measure	Healthy Volunteers n = 4	Non-Small Cell Lung Cancer Patients (NSCLC) - Pre-Therapy Scan n = 1	Non-Small Cell Lung Cancer Patients (NSCLC) - 7 to 14 Days Post Therapy n = 1
Myocardium	13.72 (0.75)	16.9 (NA)	12.3 (NA)
Brain	0.13 (0.03)	0.07 (NA)	0.06 (NA)
Kidney	109.55 (28.88)	133.0 (NA)	150.2 (NA)
Liver	54.75 (12.38)	76.5 (NA)	67.4 (NA)
Spleen	11.60 (1.73)	11.7 (NA)	10.2 (NA)
Muscle	3.04 (0.20)	3.93 (NA)	1.90 (NA)
Lungs	1.83 (0.37)	1.65 (NA)	1.76 (NA)
Bone Marrow	4.87 (1.04)	4.41 (NA)	4.11 (NA)

Adverse events

Time frame: Report initiation for all AEs and serious adverse events (SAEs) will begin immediately after the first infusion of [18F]F AraG (Visit 2) and continue until the Day 7 follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteers	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Non-Small Cell Lung Cancer Patients (NSCLC)	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Learn more or sign up for the study here!Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simon R Cherry, PhD principal investigator

UC Davis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F]F-AraG Imaging in people with Lung Cancer, Nonsmall Cell, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04678440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.