Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

STATUS

Recruiting
End date

Oct 23, 2023
participants needed

100
sponsor

University of Pennsylvania

Updated on 14 March 2022

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Accepts healthy volunteers

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. 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.

Details

Condition	Smoking, Cigarette, Smoking E-cigarette, Healthy Volunteer
Treatment	[18F]NOS
Clinical Study Identifier	NCT03721822
Sponsor	University of Pennsylvania
Last Modified on	14 March 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Participants will be 18-45 years of age
	Subject must meet one of the following criteria
	NIC vapers: current e-cigarette use of nicotine at least 5 days per week for
	the past year, no current combustible cigarette use, cannabis vaping, or
	cannabis smoking during the 30 days prior to study enrollment
	CAN vapers: current e-cigarette use of cannabis at least 5 days per week for
	the past year, no current combustible cigarette use, cannabis smoking, or
	nicotine vaping during the 30 days prior to study enrollment
	Cigarette smokers: current cigarette smoking of at least 5 cigarettes per day
	days per week for the past 1 year with no e-cigarette use (cannabis or
	nicotine) or cannabis smoking during the 30 days prior to study enrollment
	Dual combustible and e-cigarette users: current e-cigarette use of cannabis
	and/or nicotine at least 5 days per week for the past year with cigarette or
	cannabis smoking during the 30 day prior to study enrollment
	Non-Smokers: reported non-smoking history or < 100 lifetime cigarettes, < 100
	e-cigarette use episodes, and < 100 lifetime cannabis use episodes
	Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
Exclusion Criteria
	Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported
	History of kidney or liver disease per medical record review, self-report OR total bilirubin > 1.5 x ULN, ALT or AST > 3 x ULN or creatinine clearance estimated to be less than 60 ml/min at screening
	Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report
	Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening and on scan day
	History of lung trauma
	Current untreated and unstable diagnosis of substance use disorder, except nicotine use disorder or cannabis use disorder
	Active (or within the previous 4 weeks of screening) lung infection or lung disease that impact uptake of [18F]NOS (e.g. tuberculosis, cystic fibrosis)
	Positive urine drug screen for opiates, methamphetamine or cocaine at screening
	Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
	Reported regular use of nicotine or cannabis products (except edibles) other than ENDS, cigarettes, or cannabis bowls, pipes, or blunts (e.g., smokeless tobacco, nicotine replacement therapy, wax, shatter, tinctures)
	Any current or past medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

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Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation