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

Completed · Early Phase 1

Conditions studied: Lung Cancer, Nonsmall Cell

In brief

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.

Key facts

Study ID

NCT04678440

Run by

University of California, Davis

People needed

5

Starts

2021-03-31

Expected to finish

2023-02-07

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• UC Davis EXPLORER Molecular Imaging Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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