Imaging lung health effects of e-cigarette use
Hyperpolarized Xenon-129 MR Imaging of the Lung:E-cigarette Sub-study
This study is testing how e-cigarette use affects lung health in healthy young adults by using a special imaging technique to see how well their lungs work.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT04662658 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the health effects of e-cigarettes on the lungs of healthy young adults using a novel imaging technique called hyperpolarized xenon-129 MRI. The study will assess lung function and gas exchange by quantifying regional ventilation and gas uptake in the lungs. Participants will include e-cigarette users and non-smokers, with careful monitoring of their health status and lung function. The goal is to provide insights into the potential pulmonary risks associated with e-cigarette use, which is currently poorly understood.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy young adults aged 21-30 who have been using e-cigarettes for more than six months and have no history of lung disease.
Not a fit: Patients with a history of lung disease or significant medical conditions that could affect lung function will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical data on the pulmonary effects of e-cigarettes, informing public health policies and individual health decisions.
How similar studies have performed: While there have been studies on the effects of e-cigarettes, this specific approach using hyperpolarized xenon-129 MRI is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlottesville, Virginia
- Snyder Building 480 Ray C. Hunt Drive — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Yun M shim, MD — University of Virginia
- Study coordinator: Roselove Asare
- Email: rnn3b@virginia.edu
- Phone: 434-243-6074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.