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Pulmonary Inflammation Using FNOS PET in E-cigarette

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ClinicalTrials.gov Identifier: NCT03721822
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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

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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

Resource links provided by the National Library of Medicine


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.




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.



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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 criteria:

    ENDS users: 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 OR 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 OR 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

  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 cannabis, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721822


Contacts
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Contact: Zeinab Helili 215-746-3230 zeinab.helili@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 Erin.Schubert@uphs.upenn.edu

Locations
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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

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03721822     History of Changes
Other Study ID Numbers: 831205
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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

Additional relevant MeSH terms:
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Inflammation
Pneumonia
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections