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Hyperpolarized Xenon-129 MRI for Electronic Cigarette Use Effects on Lungs (e-cigarette Trial)

Phase 1 & 2
Recruiting
Led By Yun M shim, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Male and female subjects 21-30 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

e-cigarette Trial Summary

This trial will help to establish the health effects of e-cigarettes in humans by studying how they affect healthy young adults' lungs.

Who is the study for?
This trial is for healthy adults aged 21-30 who've used e-cigarettes for over 6 months or non-smokers with less than a 5 pack-year history. Participants must have no lung diseases, recent illnesses, or conditions that MRI can't be performed on (like pregnancy). People with a history of serious health issues like lung disease, infections, anemia, CNS diseases, liver disease, heart disease or renal failure cannot join.Check my eligibility
What is being tested?
The study uses Hyperpolarized Xenon-129 Magnetic Resonance Imaging (MRI) to investigate the effects of electronic cigarettes on the lungs in young adults. It aims to understand if vaping causes similar damage as seen in certain lung diseases and inform medical guidelines.See study design
What are the potential side effects?
Since this trial involves MRI imaging using hyperpolarized xenon gas there may be minimal side effects; however typical MRI-related discomforts such as loud noises during scanning and claustrophobia might occur.

e-cigarette Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function tests are normal.
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I am between 21 and 30 years old.

e-cigarette Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hyperpolarized xenon-129 MRI of the lung: e-cig sub-study

e-cigarette Trial Design

2Treatment groups
Experimental Treatment
Group I: Visit 2 Duke UniversityExperimental Treatment1 Intervention
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: The standard MR compatibility screening form will be completed. Spirometry will be performed before and after MR imaging. A limited physical exam Female subjects who could be pregnant will take a urine pregnancy test prior to imaging. 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
Group II: Visit 1 UVAExperimental Treatment1 Intervention
Visit 1 will last approximately 4 hours, and will include consenting, collection of data, questionnaires, and procedures as follows: Informed consent Demographic data Smoking history Medical history review Medication review Limited physical exam 6-minute walk test St. George's Respiratory Questionnaire (SGRQ) Baseline dyspnea index (BDI) Chronic respiratory questionnaire (CRQ) PFTs including: Pre-bronchodilator spirometry/ post bronchodilator spirometry. Body plethysmography (static lung volumes) Carbon monoxide diffusion capacity (DLCO) Collection of peripheral blood (20mL), exhaled breath condensate (EBC), and urine Hyperpolarized xenon-129 MRI (HXeMRI) if all eligibility criteria are met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,049 Total Patients Enrolled
1 Trials studying Electronic Cigarette Use
432 Patients Enrolled for Electronic Cigarette Use
Duke UniversityOTHER
2,363 Previous Clinical Trials
3,420,462 Total Patients Enrolled
Yun M shim, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Electronic Cigarette Use Clinical Trial 2023: Visit 2 Duke University Highlights & Side Effects. Trial Name: NCT04662658 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial recruiting?

"Affirmative. Clinicaltrials.gov attests that this research endeavour, which was initially published on November 5th 2020, is actively searching for participants. 24 subjects are needed from a single medical centre."

Answered by AI

Are there any vacancies still available for this research endeavor?

"According to information sourced from clinicaltrials.gov, the trial is currently accepting applications and has been since November 5th 2020. The data was last updated on December 9th of that year."

Answered by AI

Can you elaborate on any previous research that has utilized this particular treatment?

"At present, there are 15 clinical trials in process to evaluate this treatment. Unfortunately, none of these active studies have progressed to Phase 3 yet. Although the bulk of research is concentrated in Philadelphia, Pennsylvania 21 sites across the country are conducting experiments with this medication."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Hyperpolarized Xenon-129 MR Imaging of the Lung
Y. Michael Shim, MD 2020. "Hyperpolarized Xenon-129 MR Imaging of the Lung". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04662658.
~5 spots leftby Apr 2025
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