Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users
Launched by Y. MICHAEL SHIM, MD · Feb 25, 2025
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how using electronic cigarettes (e-cigarettes) affects lung health in young adults. Researchers want to see if e-cigarette use impacts the ability of the lungs to exchange gases, which is important for breathing. They will compare the lung function of 40 e-cigarette users aged 18 to 35 with 40 healthy individuals who do not use e-cigarettes. Participants will undergo tests, including a special type of MRI called Hyperpolarized Xenon MRI (HXeMRI) and a cardiopulmonary stress test, at the beginning of the study and again after 12 months.
To be eligible for this study, participants must be between 18 and 35 years old, must have been using e-cigarettes regularly for at least six months, and should be in good health with no history of lung or certain other serious diseases. The trial is currently recruiting participants, and those who join can expect to have their lung function tested with various methods and to learn more about how their e-cigarette use might be affecting their health over time.
Gender
ALL
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.
- • -
- 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.
About Y. Michael Shim, Md
Dr. Y. Michael Shim, MD, is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a robust background in clinical medicine and a focus on innovative therapeutic approaches, Dr. Shim leads studies aimed at evaluating the efficacy and safety of novel treatments across various therapeutic areas. His dedication to rigorous scientific methodologies and ethical standards ensures that each trial meets the highest quality benchmarks, fostering collaboration between researchers, healthcare providers, and patients. Dr. Shim's leadership in clinical trials reflects his passion for transforming healthcare through evidence-based practices and cutting-edge research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlottesville, Virginia, United States
Durham, North Carolina, United States
Patients applied
Trial Officials
Yun M Shim, MD
Principal Investigator
University of Virginia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported