Pulmonary Inflammation Using FNOS PET in E-cigarette

• ClinicalTrials.gov Identifier: NCT03721822
• Recruitment Status: Recruiting
• First Posted: October 26, 2018
• Last Update Posted: September 18, 2019
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Smoking, Cigarette; Smoking E-cigarette; Healthy Volunteer	Drug: [18F]NOS	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users
• Actual Study Start Date: October 23, 2018
• Estimated Primary Completion Date: October 23, 2020
• Estimated Study Completion Date: October 23, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Electronic Nicotine Delivery System (ENDS); Reported daily use of an ENDS product and have not smoked combustible cigarettes or cannabis for at least 12 months prior to study enrollment and total smoking history of < 5 pack years	Drug: [18F]NOS; [18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
Experimental: Traditional Cigarette Smokers; Reported current cigarette smoking of at least 10 cigarettes per day for at least 1 year with no history of ENDS use or cannabis use for at least 12 months prior to study enrollment	Drug: [18F]NOS; [18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
Experimental: Non-smokers; Reported non-smoking history or < 100 lifetime cigarettes smoked and/or < 100 lifetime cannabis use episodes with no current use of tobacco/nicotine or cannabis	Drug: [18F]NOS; [18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.

Outcome Measures

Primary Outcome Measures :

1. lung inflammation using [18F]NOS PET/CT [ Time Frame: 3 years ]
   lung inflammation using [18F]NOS PET/CT and compare uptake in ENDS users to traditional cigarette smokers and non-smokers.

Secondary Outcome Measures :

1. relationship between [18F]NOS uptake and peripheral inflammatory biomarkers [ Time Frame: 3 years ]
   relationship between [18F]NOS uptake measures and established peripheral inflammatory biomarkers (e.g. C-reactive protein and Il-6).
2. differences in brain inflammation between three cohort using [18F]NOS PET/CT] [ Time Frame: 3 years ]
   Using [18F]NOS PET/CT to explore relative differences in brain inflammation between ENDS users, traditional cigarette smokers and non-smokers.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Participants will be 18-45 years of age

2. Subject must meet one of the following set of criteria:

   ENDS users: reported daily use of an ENDS product, have not smoked combustible cigarettes frequently for at least 6 months prior to study enrollment OR Cigarette smokers: reported current cigarette smoking of at least 5 cigarettes per day for at least 1 year with no history of ENDS use or cannabis use for at least 6 months prior to study enrollment OR Non-Smokers: reported non-smoking history or < 100 lifetime cigarettes smoked and no history of ENDS use with no current use of tobacco/nicotine

3. 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:

1. 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.
2. Self-reported use of menthol flavored e-liquids or menthol cigarettes
3. Current untreated and unstable diagnosis of substance use disorder
4. Breath alcohol concentration (BrAC) ≥ 0.01 or positive urine drug screen for opiates, methamphetamine or cocaine at screening
5. Reported regular use of nicotine products other than ENDS or cigarettes (e.g. smokeless tobacco, nicotine replacement therapy)
6. Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported
7. 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.
8. Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report
9. History of lung trauma
10. 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)
11. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
12. Any current 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

Contacts and Locations

Contacts

Contact: Zeinab Helili; 215-746-3230; zeinab.helili@uphs.upenn.edu

Contact: Erin Schubert; 215-573-6569; Erin.Schubert@uphs.upenn.edu

Locations

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Zeinab Helili 215-746-3230 zeinab.helili@uphs.upenn.edu

Contact: Erin Schubert 215-573-6569 Erin.Schubert@uphs.upenn.edu

Sponsors and Collaborators

University of Pennsylvania

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03721822 History of Changes
• Other Study ID Numbers: 831205
• First Posted: October 26, 2018
• Last Update Posted: September 18, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia; Inflammation; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections