RECRUITING

Imaging Sex Differences in Smoking-Induced Pulmonary Inflammation

Conditions

Smoking, Cigarette Smoking E-cigarette Healthy Volunteer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-10-23

Study Completion:2026-10-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03721822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants will be 18-45 years of age 2. Subject must meet one of the following criteria: 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.	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 and on scan day. 2. Current untreated and unstable diagnosis of substance use disorder, except nicotine use disorder or cannabis use disorder 3. Positive urine drug screen for opiates, methamphetamine or cocaine at screening 4. 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) 5. Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported 6. Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report 7. History of lung trauma 8. 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) 9. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 10. 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

Inclusion Criteria

Exclusion Criteria

1. Participants will be 18-45 years of age
2. Subject must meet one of the following criteria:
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.

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 and on scan day.
2. Current untreated and unstable diagnosis of substance use disorder, except nicotine use disorder or cannabis use disorder
3. Positive urine drug screen for opiates, methamphetamine or cocaine at screening
4. 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)
5. Current unstable and/or untreated major depression or psychotic disorder per medical record review or self-reported
6. Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical record review or self-report
7. History of lung trauma
8. 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)
9. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
10. 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

Contacts and Locations

Study Contact

Erin Schubert

CONTACT

215-573-6569

erinschu@pennmedicine.upenn.edu

Principal Investigator

Jacob Dubroff, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Jacob Dubroff, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-23

Study Completion Date2026-10-23

Study Record Updates

Study Start Date2018-10-23

Study Completion Date2026-10-23

Terms related to this study

Additional Relevant MeSH Terms

Smoking, Cigarette
Smoking E-cigarette
Healthy Volunteer