lung cancer lung carcinoma
Conditions
Interventions
All patients will undergo [18F]F-AraG PET scanning according to the
institutional pharmacokinetic tracer modeling protocols
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed NSCLC, a histological biopsy is mandatory. 2. Patients that are resectable upfront as per multidisciplinary tumor board evaluation. 3. Be willing and able to provide written informed consent for the trial. 4. Be above 18 years of age on day of signing informed consent. 5. Have a performance status of 0-1 on the ECOG Performance Scale at screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of screening. Inhaled or topical steroids, and adrenal replacement steroid >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 2. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 3. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last [18F]F-AraG PET scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic tumor tracer uptake parameters will be summarized to perform tracer kinetic modeling using standard nonlinear regression techniques to fit the dynamic [18F]F-AraG tumor time activity curves (TACs) to different (i.e., 1-tissue, irreversible 2-tissue, and reversible 2-tissue) compartment models using the measured metabolite corrected plasma time-activity curve as input function. The optimal model will be selected based on the goodness of fit. The most appropriate parameter will be chosen depending on the optimal model and its test-retest variability. Dynamic uptake parameters of interest will be correlated with simplified static uptake parameters derived from the whole-body scans. Correlations will be made between hotspots and cold-spots as seen on the [18F]F-AraG PET and the corresponding spots on the resection specimen for automated quantification of CD8+ cells using VECTRA and tumor inflammation signature using gene expression analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed