Hyperpolarized Xenon-129 MR Imaging of the Lung

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT04662658
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • E-Cig Use

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hyperpolarized Xenon -129 MRI — DRUG
    e-cigarette sub-study

Study Details

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 Dates

Start date
Nov 5, 2020
Status verified
Dec 2020
Primary completion
Dec 31, 2022
Completion
Dec 31, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

Hyperpolarized xenon-129 MRI of the lung: e-cig sub-study [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Snyder Building 480 Ray C. Hunt DriveCharlottesvilleVirginia22908
Roselove Asare, MA
[email protected]
434-243-6074
Yun M Shim, MD (PRINCIPAL_INVESTIGATOR)

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Snyder Building 480 Ray C. Hunt Drive· Charlottesville, VA

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