Clinical trial NCT06856525: Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users
Official title: Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Electronic Cigarette Related Lung Damage
Keywords: hyperpolarized xenon-129 MRI
cardiopulmonary stress test
lung damage
vaping
healthy young adult
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Duke University
name: George Mason University
First posted: 2025-03-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 Participants who are healthy with less than 6 months of smoking history and electronic cigarette users with more than 6 months of electronic cigarette usage. Subjects will be recruited and consented at the University of Virginia and Duke University.
Primary purpose: DIAGNOSTIC

Brief summary: A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon MRI (HXeMRI) results with the cardiopulmonary stress test at the initial visit and a follow-up visit 12 months later.

Detailed description: Electronic cigarettes have been commercialized as a "less harmful" alternative to traditional cigarettes. Electronic cigarettes generate vapor from ingredients containing well-known toxic materials such as carbonyls, tobacco-specific N-nitrosamines, and heavy metals. Nonhuman studies show that Electronic cigarettes cause pulmonary epithelial, endothelial, and vascular dysfunction. Electronic cigarette use has also been associated with cardiac and pulmonary diseases, including severe respiratory failure. Our preliminary studies suggest that we can detect subtle early changes in healthy young e-cigarette users by hyperpolarized xenon-129 MR imaging. We anticipate the following results from the three primary analyses. First, there will be significantly impaired gas exchange in electronic cigarette users compared to healthy controls at the initial and follow-up visits. Second, gas exchange impairment in electronic cigarette users will increase after an additional 12 months of electronic cigarette use. Further, as a secondary analysis, we speculate that because electronic cigarette users exhaust their cardiopulmonary reserve at rest, they will have reduced physical fitness detectable by the 6-minute walk and Cardio-pulmonary exercise tests.

Eligibility criteria: Inclusion Criteria:

1. Ages between 18 and 35 years old.
2. At their baseline health
3. Ability to understand a written informed consent form and comply with the requirements of the study.
4. Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
5. Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
6. At baseline, normal spirometry with or without bronchodilator, plethysmograph lung volume, carbon monoxide diffusion capacity, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference.

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Exclusion Criteria:

1. History of any other lung disease
2. History of brain diseases including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure
3. Acute infection of any kind previous 6 weeks
4. Pregnancy or a possibility of pregnancy
5. Anemia
6. Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
7. Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study.
8. Using a non-closed container, custom-made electronic cigarette juice, or inability for the study team to access "closed-container" and "pre-packaged" electronic cigarette juice for chemical analysis
9. Significant history of smoking other substances in the past year.

Primary outcomes:
measure: Comparison between e-cig user vs. healthy participants at baseline and 12 month later
timeFrame: baseline and 12 month follow-up
measure: Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up
timeFrame: baseline and 12 months follow-up
measure: Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up
timeFrame: Baseline and 12 months follow up
Secondary outcomes:
measure: Acute Effects of eCig use at baseline and 12 months follow-up
timeFrame: baseline and 12 months follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Yun M Shim, MD
role: PRINCIPAL_INVESTIGATOR
References: