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RecruitingAccepts healthy volunteersPhase 1/Phase 2

Hyperpolarized Xenon-129 MR Imaging of the Lung

University of Virginia · with Duke University · NCT04662658

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
24
US sites recruiting
1
Study start
November 5, 2020
Record last updated
December 10, 2020

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Hyperpolarized Xenon -129 MRI

Conditions: E-Cig Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Recruiting US locations

  • Snyder Building 480 Ray C. Hunt Drive

    Charlottesville, VA 22908

    Site contact: Roselove Asare, MA · 434-243-6074 · rnn3b@virginia.edu

Study contacts (from the official record)

  • Roselove Asare · 434-243-6074 · rnn3b@virginia.edu
All smoking & vaping studies in Virginia →
Hyperpolarized Xenon-129 MR Imaging of the Lung (NCT04662658) | Bored Studies