Status:
RECRUITING
Hyperpolarized Xenon-129 MR Imaging of the Lung
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Duke University
Conditions:
E-Cig Use
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 pulm...
Detailed Description
This exploratory proposal will exploit 3D hyperpolarized xenon-129 MRI (HXeMRI), an imaging tool that our research group has pioneered, to address this urgent need. The HXeMRI technique has unique abi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04662658
Start Date
November 5 2020
End Date
December 1 2025
Last Update
December 10 2020
Active Locations (1)
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1
Snyder Building 480 Ray C. Hunt Drive
Charlottesville, Virginia, United States, 22908