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

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 16, 2020

Keywords

ClinConnect Summary

\[18F\]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 dev...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years.
• • 2. Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.
• • 3. Willingness and ability to comply with all protocol required procedures.
• • 4. 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:
• • 5. Patients with histologically confirmed advanced, locally advanced, or localized NSCLC.
• • 6. 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
• • 7. 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.
• • 8. 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.
• • 9. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• • 10. Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.
• Exclusion Criteria:
• Subjects are not eligible if they meet ANY of the following criteria:
• • 1. Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
• • 2. History of recent COVID-19 infection within the last 2 months OR history of COVID requiring hospitalization with lung injury at Investigator's discretion
• • 3. 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
• • 4. Subjects receiving therapy with nucleoside analogs including but not limited to: acyclovir, valaclovir, penciclovir, famciclovir, ganciclovir, ribavirin, valganciclovir, glanciclovir
• • 5. Pregnant women or nursing mothers.
• • 6. Body weight more than 240 kg (529 pounds)
• For NSCLC subjects only:
• • 7. Prior Treatment with anti-PD-1/PD-L1 immunotherapy.
• • For Healthy subjects
• • 8. No primary care physician