Hyperpolarized Xenon-129 MR Imaging of the Lung:E-cigarette Sub-study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
United States
Virginia
Snyder Building 480 Ray C. Hunt Drive
RECRUITING
Charlottesville
Contact Information
Primary
Roselove Asare
rnn3b@virginia.edu
434-243-6074
Time Frame
Start Date: 2020-11-05
Estimated Completion Date: 2025-12
Participants
Target number of participants: 24
Treatments
Other: Visit 1 UVA
Visit 1 will last approximately 4 hours, and will include consenting, collection of data, questionnaires, and procedures as follows:~1. Informed consent~2. Demographic data~3. Smoking history~4. Medical history review~5. Medication review~6. Limited physical exam~7. 6-minute walk test~8. St. George's Respiratory Questionnaire (SGRQ)~9. Baseline dyspnea index (BDI)~10. Chronic respiratory questionnaire (CRQ)~11. PFTs including:~ 1. Pre-bronchodilator spirometry/ post bronchodilator spirometry.~ 2. Body plethysmography (static lung volumes)~ 3. Carbon monoxide diffusion capacity (DLCO)~12. Collection of peripheral blood (20mL), exhaled breath condensate (EBC), and urine~13. Hyperpolarized xenon-129 MRI (HXeMRI) if all eligibility criteria are met
Other: Visit 2 Duke University
Visit 2 will last about 3 hours, and will occur within 2-12 weeks of Visit 1. The purpose of this study visit is to obtain a measure of basic test-retest variability on 6 e-cigarette users and 6 control subjects. Participants will be selected based on age and sex matching needs at the time of enrollment.~During Visit 2, changes in health since Visit 1 will be assessed. In addition, the following will be done in accordance with the parent protocol:~1. The standard MR compatibility screening form will be completed.~2. Spirometry will be performed before and after MR imaging.~3. A limited physical exam~4. Female subjects who could be pregnant will take a urine pregnancy test prior to imaging.~5. Xenon MRI will be performed~In addition to the above, the following will be completed:~* Carbon monoxide diffusion capacity (DLCO)~* Peripheral blood (20mL) and urine
Sponsors
Leads: University of Virginia
Collaborators: Duke University

This content was sourced from clinicaltrials.gov