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

• Status: Enrolling by invitation
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot study, healthy volunteers and patients with advanced 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Collaborator: CellSight Technologies, Inc.

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 NSCLC.

6. Planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease.

7. At least 1 tumor lesion > 1 cm 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. Pregnant women or nursing mothers.

3. Body weight more than 240 kg (529 pounds)

For NSCLC subjects only:

4. Prior Treatment with anti-PD-1/PD-L1 immunotherapy.

For Healthy subjects

5. No primary care physician