[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients (NCT04678440) | Clinical Trial Compass
CompletedEarly Phase 1
[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients
United States5 participantsStarted 2021-03-31
Plain-language 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 Tomography scanner to obtain preliminary data regarding pharmacokinetics and early biodistribution images.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
What they're measuring
1
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues
Timeframe: Baseline
2
Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects
Timeframe: Baseline and 7-14 days after first dose of PD-1/PD-L1
3
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake
Timeframe: Baseline and 7-14 days after first dose of PD-1/PD-L1
✕. 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)
✕. Prior Treatment with anti-PD-1/PD-L1 immunotherapy.