Hyperpolarized Xenon-129 MR Imaging of the Lung

Recruiting now · Phase 1/Phase 2

Conditions studied: E-Cig Use

In brief

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.

Key facts

Study ID

NCT04662658

Run by

University of Virginia

People needed

24

Starts

2020-11-05

Expected to finish

2025-12-01

Last updated by the study team

2020-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects 21-30 years of age
• At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator
• Ability to understand a written informed consent form and comply with the requirements of the study.
• 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).
• 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)

You may not qualify if…

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

Where it is running

• Snyder Building 480 Ray C. Hunt Drive — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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