Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 35Years
All Genders
Healthy Volunteers
NCT06856525

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

Led by Y. Michael Shim, MD · Updated on 2026-03-17

80

Participants Needed

2

Research Sites

419 weeks

Total Duration

On this page

Sponsors

Y

Y. Michael Shim, MD

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 35Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages between 18 and 35 years old.
  • At their baseline health.
  • Ability to understand a written informed consent form and comply with the study requirements.
  • Exclusive long-term electronic cigarette use for more than six months, at least three days per week.
  • Use of "closed-container" or "pre-packaged" electronic cigarette juices containing nicotine.
  • Healthy subjects must have normal baseline lung function tests; e-cigarette users may have normal or abnormal spirometry with FEV1/FVC between 26-70.
Not Eligible

You will not qualify if you...

  • History of any other lung disease.
  • History of brain diseases including stroke and dementia, end-stage liver disease, coronary artery disease, or renal failure.
  • Acute infection within the previous 6 weeks.
  • Pregnancy or possibility of pregnancy.
  • Anemia.
  • Inability to undergo pulmonary function testing, cardiopulmonary exercise testing, or MRI.
  • Prior cigarette smoking of more than one pack-year within six months before enrollment.
  • Use of non-closed container, custom-made electronic cigarette juice, or inability to access closed-container juices for chemical analysis.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

2

University of Virginia

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

R

Roselove Asare, MA

CONTACT

C

Caleigh Smith, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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