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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 : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE October 23, 2018
Estimated Primary Completion Date October 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
quantify the extent of lung inflammation using [18F]NOS PET/CT [ Time Frame: 3 years ]
To quantify the extent of lung inflammation using [18F]NOS PET/CT and compare uptake in ENDS users to traditional cigarette smokers and non-smokers.
Change History Complete list of historical versions of study NCT03721822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • relationship between [18F]NOS uptake and peripheral inflammatory biomarkers [ Time Frame: 3 years ]
    To explore the relationship between [18F]NOS uptake measures and established peripheral inflammatory biomarkers (e.g. C-reactive protein and Il-6).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary Inflammation Using FNOS PET in E-cigarette
Official Title  ICMJE Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Smoking, Cigarette
  • Smoking E-cigarette
  • Healthy Volunteer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: [18F]NOS
  • 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
    Intervention: Drug: [18F]NOS
  • 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
    Intervention: Drug: [18F]NOS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2021
Estimated Primary Completion Date October 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zeinab Helili 215-746-3230 zeinab.helili@uphs.upenn.edu
Contact: Erin Schubert 215-573-6569 Erin.Schubert@uphs.upenn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03721822
Other Study ID Numbers  ICMJE 831205
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pennsylvania
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP