Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

Healthy Volunteer Clinical Trial

Official title: Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users

Status Recruiting

Clinical Trial Summary

The purpose of this research is to measure the extent of lung inflammation between different groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a type of imaging drug that is labeled with a radioactive tag and injected into the body.

Clinical Trial Description

This study will see how the tracer is taken up in the lungs using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). [18F]NOS is an experimental radioactive molecule used in PET imaging to measure inflammation in various organs in the body. Investigators are interested in studying whether there are differences in lung inflammation between E-cigarette users (vapers) cigarette smokers and non-smokers. [18F]NOS has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. The use of [18F]NOS in this study is allowed under an Investigational New Drug Application approved by the FDA.

Investigators are also going to be studying how the information from the PET/CT scan compares to other markers of inflammation in the blood. During the PET scan, Investigators will image Brain and Lungs in order to see if there is a difference between inflammation seen in the brain and the lungs and if these differences change depending on whether a subject is a smoker, e-cigarette user or non-smoker.

Consented participant in this study will undergo one (1) experimental [18F]NOS PET/CT scan. During the scan, PET/CT images will be taken of participant chest/torso in order to capture their lungs and a short image will be taken of their brain. Blood samples will be taken at various time points to test for markers of inflammation and to measure the concentration of the tracer in participants blood during the scan and participants will undergo some specific psychological questionnaires and tasks. ;

Related Conditions & MeSH terms

• Healthy Volunteer
• Inflammation
• Pneumonia
• Smoking E-cigarette
• Smoking, Cigarette

• NCT number: NCT03721822
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Erin Schubert
• Phone: 215-573-6569
• Email: erinschu@pennmedicine.upenn.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: October 23, 2018
• Completion date: October 23, 2024