Recruiting
Phase 1
Phase 2

Hyperpolarized Xenon-129

Sponsor:

University of Virginia

Code:

NCT04662658

Conditions

E-Cig Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized Xenon -129 MRI

Study Details

Brief summary:

Over the past 10 years, electronic cigarettes (e-cigarettes, EC) have been commercialized as a "less harmful" alternative to traditional cigarettes.1,2 However, e-cigarettes are believed to cause pulmonary epithelial, endothelial and vascular dysfunction, and to cause murine phenotypes similar to those of human COPD. Recently, "spiked" vape juice has been linked to severe lung damage. Unfortunately, the effects of e-cigarettes on the human lungs are still poorly understood, especially in healthy young adults. Therefore, establishing the health effects of e-cigarettes in humans is of paramount importance to guide medical and regulatory decision making. Its widespread use and immense popularity among teenagers and young adults have caused major concern given potentially significant addictive and detrimental long-term health effects.

Conditions

E-Cig Use

Study ID

NCT04662658

Start date

Nov 5, 2020

Status verified date

Dec, 2020

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Male and female subjects 21-30 years of age
2. At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator
3. Ability to understand a written informed consent form and comply with the requirements of the study.
4. E-cigarette use for more than 6 months preceding the date of enrollment and less than a 5 pack year smoking history (e-cigarette users) OR less than a 5 pack year smoking history (non-smoker group).
5. No diagnosis of any lung disease (pre-bronchodilator FEV1/FVC normal on the day of screening defined by > 95thCI of NHANES III, ATS/ERS guideline)

Exclusion Criteria:

1. History of any lung disease
2. Control (non-smoking) group: History of illegal drug use by inhalation
3. History of CNS disease including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure
4. Acute infection of any kind in the previous 6 weeks
5. Pregnancy or a possibility of pregnancy
6. Anemia
7. Inability to undergo MR imaging based on the standard clinical criteria for MRI

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Visit 1 UVA

Visit 1 will last approximately 4 hours, and will include consenting, collection of data, questionnaires, and procedures as follows:

1. Informed consent
2. Demographic data
3. Smoking history
4. Medical history review
5. Medication review
6. Limited physical exam
7. 6-minute walk test
8. St. George's Respiratory Questionnaire (SGRQ)
9. Baseline dyspnea index (BDI)
10. Chronic respiratory questionnaire (CRQ)
11. PFTs including:

1. Pre-bronchodilator spirometry/ post bronchodilator spirometry.
2. Body plethysmography (static lung volumes)
3. Carbon monoxide diffusion capacity (DLCO)
12. Collection of peripheral blood (20mL), exhaled breath condensate (EBC), and urine
13. Hyperpolarized xenon-129 MRI (HXeMRI) if all eligibility criteria are met

other: Visit 2 Duke University

Visit 2 will last about 3 hours, and will occur within 2-12 weeks of Visit 1. The purpose of this study visit is to obtain a measure of basic test-retest variability on 6 e-cigarette users and 6 control subjects. Participants will be selected based on age and sex matching needs at the time of enrollment.

During Visit 2, changes in health since Visit 1 will be assessed. In addition, the following will be done in accordance with the parent protocol:

1. The standard MR compatibility screening form will be completed.
2. Spirometry will be performed before and after MR imaging.
3. A limited physical exam
4. Female subjects who could be pregnant will take a urine pregnancy test prior to imaging.
5. Xenon MRI will be performed

In addition to the above, the following will be completed:

  • Carbon monoxide diffusion capacity (DLCO)
  • Peripheral blood (20mL) and urine

Interventions

Hyperpolarized Xenon -129 MRI

e-cigarette sub-study

Primary outcome measure

  • Hyperpolarized xenon-129 MRI of the lung: e-cig sub-study [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Roselove Asare

434-243-6074rnn3b@virginia.edu

Locations

Snyder Building 480 Ray C. Hunt Drive

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Roselove Asare, MA

434-243-6074rnn3b@virginia.edu

Principal Investigator:

Yun M Shim, MD

More Information

Sponsor

University of Virginia

Last update posted

Dec 10, 2020

Last verified

Dec, 2020

Keywords

  • e-cigarette use with young adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2020-12-10.