Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT04662658

Hyperpolarized Xenon-129 MR Imaging of the Lung

Led by University of Virginia · Updated on 2020-12-10

24

Participants Needed

1

Research Sites

264 weeks

Total Duration

On this page

Sponsors

U

University of Virginia

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Hyperpolarized Xenon-129 MR Imaging of the Lung

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 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 screening day defined by > 95thCI of NHANES III, ATS/ERS guideline)
Not Eligible

You will not qualify if you...

  • 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 possibility of pregnancy
  • Anemia
  • Inability to undergo MR imaging based on standard clinical MRI criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Trial Site Locations

Total: 1 location

1

Snyder Building 480 Ray C. Hunt Drive

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

R

Roselove Asare

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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