CompletedEarly Phase 1

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

United States5 participantsStarted 2021-03-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline

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

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

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

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

Trial details

NCT IDNCT04678440

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-07

Results submitted2025-01-22

View on ClinicalTrials.gov More Lung Cancer, Nonsmall Cell trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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

What they're measuring

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

Timeframe: Baseline

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

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

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

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria