Status:
COMPLETED
[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
CellSight Technologies, Inc.
Conditions:
Lung Cancer, Nonsmall Cell
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 To...
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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04678440
Start Date
March 31 2021
End Date
February 7 2023
Last Update
July 2 2025
Active Locations (1)
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1
UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, United States, 95816