RecruitingPhase 2Phase 3NCT06856525

Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology

Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Healthy Participants and E-cigarette Users


Sponsor

Y. Michael Shim, MD

Enrollment

80 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon MRI (HXeMRI) results with the cardiopulmonary stress test at the initial visit and a follow-up visit 12 months later.


Eligibility

Min Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized lung MRI technique involving hyperpolarized xenon gas (HXe-129 MRI) to detect early, subtle damage to the lungs caused by long-term e-cigarette use, even before standard lung function tests show a problem. Researchers will compare gas exchange capacity and physical fitness between 40 e-cigarette users and 40 healthy non-users at the start of the study and again one year later. Adults aged 18–35 who exclusively use closed-container, nicotine-containing e-cigarettes for at least 6 months (at least 3 times per week) may be eligible; healthy controls must have normal lung function tests. Participation includes MRI scans, standard lung function tests, a cardiopulmonary exercise test, and a 6-minute walk at two time points 12 months apart. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHyperpolarized xenon 129

Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.

DIAGNOSTIC_TESTCardiopulmonary Stress Test

Exercise stress test to evaluate cardiac and pulmonary fitness.

DIAGNOSTIC_TESTPulmonary Function Test

Standard clinic pulmonary function test to evaluate lung function

DIAGNOSTIC_TESTChest CT

Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement.


Locations(2)

Duke University

Durham, North Carolina, United States

University of Virginia

Charlottesville, Virginia, United States

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NCT06856525