Using MRI to Measure Lung Damage in Young E-cigarette Users

Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Healthy Participants and E-cigarette Users

This study is trying to see how using e-cigarettes affects lung health and fitness in young people by comparing them to those who don’t use e-cigarettes over a year.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Locations: 2 sites (Durham, North Carolina and 1 other locations)
• Trial ID: NCT06856525 on ClinicalTrials.gov

What this trial studies

This study involves a longitudinal assessment of 40 young electronic cigarette users and 40 healthy controls to evaluate the impact of e-cigarette use on lung function. Participants will undergo hyperpolarized xenon-129 MRI and cardiopulmonary stress tests at the beginning and after 12 months. The goal is to quantify changes in pulmonary gas exchange capacity and physical fitness related to e-cigarette use. The study aims to provide insights into the early effects of vaping on lung health.

Who should consider this trial

Good fit: Ideal candidates are healthy young adults aged 18 to 35 who have been using e-cigarettes regularly for over six months.

Not a fit: Patients with a history of lung disease or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify early lung damage in young e-cigarette users, leading to better prevention and treatment strategies.

How similar studies have performed: While there is emerging research on the effects of e-cigarettes, this specific approach using hyperpolarized xenon-129 MRI is relatively novel and has not been extensively tested.

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. Healthy subjects must be at baseline normal spirometry with or without bronchodilator, plethysmograph lung volume, DLCO, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference. (PFT will be completed during a screening visit); Ecigarette users can have normal spirometry (FEV1/FVC\>70) or abnormal spirometry (FEV1/FVC 26-70)

   \-

Exclusion Criteria:

1. History of any other lung disease
2. History of brain diseases including stroke (CNS) 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

Where this trial is running

Durham, North Carolina and 1 other locations

• Duke University — Durham, North Carolina, United States (Recruiting)
• University of Virginia — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Yun M Shim, MD — University of Virginia
• Study coordinator: Roselove Asare, MA

Conditions Electronic Cigarette Related Lung Damage; hyperpolarized xenon-129 MRI; cardiopulmonary stress test; lung damage; vaping; healthy young adult