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NCT Number: NCT06856525

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke University, Durham, North Carolina, United States

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About this study

Electronic cigarettes have been commercialized as a "less harmful" alternative to traditional cigarettes. Electronic cigarettes generate vapor from ingredients containing well-known toxic materials such as carbonyls, tobacco-specific N-nitrosamines, and heavy metals. Nonhuman studies show that Electronic cigarettes cause pulmonary epithelial, endothelial, and vascular dysfunction. Electronic cigarette use has also been associated with cardiac and pulmonary diseases, including severe respiratory failure. Our preliminary studies suggest that we can detect subtle early changes in healthy young e-cigarette users by hyperpolarized xenon-129 MR imaging. We anticipate the following results from the three primary analyses. First, there will be significantly impaired gas exchange in electronic cigarette users compared to healthy controls at the initial and follow-up visits. Second, gas exchange impairment in electronic cigarette users will increase after an additional 12 months of electronic cigarette use. Further, as a secondary analysis, we speculate that because electronic cigarette users exhaust their cardiopulmonary reserve at rest, they will have reduced physical fitness detectable by the 6-minute walk and Cardio-pulmonary exercise tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages between 18 and 35 years old.
  • At their baseline health
  • Ability to understand a written informed consent form and comply with the requirements of the study.
  • Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
  • Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
  • Healthy subjects must be at baseline normal spirometry with or without bronchodilator, plethysmograph lung volume, DLCO, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference. (PFT will be completed during a screening visit); Ecigarette users can have normal spirometry (FEV1/FVC>70) or abnormal spirometry (FEV1/FVC 26-70)

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Exclusion criteria

  • History of any other lung disease
  • History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure
  • Acute infection of any kind previous 6 weeks
  • Pregnancy or a possibility of pregnancy
  • Anemia
  • Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
  • Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study.
  • Using a non-closed container, custom-made electronic cigarette juice, or inability for the study team to access "closed-container" and "pre-packaged" electronic cigarette juice for chemical analysis

Treatment and study plan

Hyperpolarized Xenon 129

Drug

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

Other names: 129HxeMRI

Cardiopulmonary Stress Test

Diagnostic Test

Exercise stress test to evaluate cardiac and pulmonary fitness.

Other names: CPET

Pulmonary Function Test

Diagnostic Test

Standard clinic pulmonary function test to evaluate lung function

Other names: PFT

Chest CT

Diagnostic Test

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

Primary outcomes

  1. Comparison between e-cig user vs. healthy participants at baseline and 12 month later

    Time frame: baseline and 12 month follow-up

    Hyperpolarized MRI (ventilation defect, RBC/Gas, Membrane/Gas, and RBC/membrane numbers) capillaries using HXeMRI, and corroborate the HXeMRI signatures with the CPET for 40 healthy participants and 40 e-cigarette users use at an initial visit (V1) and a follow-up visit 12-months later (V2).

  2. Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up

    Time frame: baseline and 12 months follow-up

    Cardiopulmonary stress test maximum oxygen uptake

  3. Acute effects of e-cig in e-cig users before and after using one usual dose at baseline and 12 months follow-up

    Time frame: Baseline and 12 months follow up

    Pulmonary Function Test with 6 minute walk test

Secondary outcomes

  1. Acute Effects of eCig use at baseline and 12 months follow-up

    Time frame: baseline and 12 months follow-up

    blood levels of 32 chemical toxins

Study contacts

Contact information is provided by the study sponsor or research team.

Caleigh Smith, BS

CONTACT

[email protected]

434-243-1140

Roselove Asare, MA

CONTACT

[email protected]

4342436074

Sponsors and collaborators

Lead sponsor

Y. Michael Shim, MD

Other

Collaborators

  • Duke University
  • George Mason University

Registry information

Official study title

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

Acronym: ECig

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Mar 4, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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