This early phase I trial evaluates the use of fluorine F 18 nitric oxide synthase ([18F]NOS) positron emission tomography (PET)/computed tomography (CT) imaging for measuring the extent of smoking-induced lung inflammation. A radioactive tracer, such as [18F]NOS, is a type of imaging drug that is labeled with a radioactive tag and injected into the body. This trial studies how the tracer is taken up in the lungs using a PET/CT scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, such as [18F]NOS. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. [18F]NOS PET/CT imaging may be useful for identifying and measuring inflammation and function in the lungs of those who vape, those who smoke combustible cigarettes, and non-smokers.
Additional locations may be listed on ClinicalTrials.gov for NCT03721822.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Temporarily closed to accrual
Contact: Jacob Dubroff
Phone: 215-662-3041
PRIMARY OBJECTIVE:
I. To quantify the extent of lung inflammation using [18F]NOS PET/CT and compare uptake in nicotine vapers to cannabis vapers, dual users, traditional cigarette smokers, and non-smokers.
SECONDARY OBJECTIVES:
I. To explore the relationship between [18F]NOS uptake measures and established peripheral inflammatory biomarkers (e.g. C-reactive protein and Il-6).
II. To examine the effect of vaping nicotine, vaping cannabis, dual use, cigarette smoking, and not smoking or vaping on biomarkers of airway (e.g., fractional exhaled nitric oxide [FeNO]) and lung function (e.g., forced expiratory volume 1 and forced vital capacity).
OUTLINE:
Patients receive [18F]NOS intravenously (IV) and then undergo whole body PET/CT scan over 60 minutes. Patients also undergo blood sample collection on trial.
After completion of study intervention, patients are follow up on the next available business day.
Trial PhasePhase O
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJacob Dubroff