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

NCT06856525 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Electronic Cigarette Related Lung Damage

Interventions

DRUG

Hyperpolarized 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_TEST

Cardiopulmonary Stress Test

Exercise stress test to evaluate cardiac and pulmonary fitness.

DIAGNOSTIC_TEST

Pulmonary Function Test

Standard clinic pulmonary function test to evaluate lung function

DIAGNOSTIC_TEST

Chest CT

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

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • George Mason University

    collaborator OTHER

  • Y. Michael Shim, MD

    lead OTHER

Principal Investigators

  • Yun M Shim, MD · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2028-12-31
Completion
2032-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856525 on ClinicalTrials.gov