Recruiting
Phase 2
Phase 3

Dissolved Phase HXe-129

Sponsor:

Y. Michael Shim, MD

Code:

NCT06856525

Conditions

Electronic Cigarette Related Lung Damage

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Hyperpolarized xenon 129

Cardiopulmonary Stress Test

Pulmonary Function Test

Chest CT

Study Details

Brief 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

Study ID

NCT06856525

Start date

Dec 19, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Ages between 18 and 35 years old.
2. At their baseline health
3. Ability to understand a written informed consent form and comply with the requirements of the study.
4. Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
5. Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
6. 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:

1. History of any other lung disease
2. History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure
3. Acute infection of any kind previous 6 weeks
4. Pregnancy or a possibility of pregnancy
5. Anemia
6. Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
7. Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study.
8. 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Healthy Participants

Young, healthy subjects without any lung disease or other inflammatory diseases.

experimental: eCig user

Young, otherwise healthy subjects who have used electronic cigarettes for at least 6 months past year.

Interventions

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.

Cardiopulmonary Stress Test

Exercise stress test to evaluate cardiac and pulmonary fitness.

Pulmonary Function Test

Standard clinic pulmonary function test to evaluate lung function

Chest CT

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

Primary outcome measure

  • Comparison between e-cig user vs. healthy participants at baseline and 12 month later [ Time Frame: baseline and 12 month follow-up ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Roselove Asare, MA

4342436074rnn3b@virginia.edu

Caleigh Smith, BS

434-243-1140RJT3QF@uvahealth.org

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Cody Blanton, BS

919-668-7575cody.blanton@duke.edu

Principal Investigator:

Joseph Mammarappallil, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Yun M Shim, MD

434-924-5210yss6n@virginia.edu

Roselove N Asare, MA

434-243-6074rnn3b@virginia.edu

Principal Investigator:

Yun M Shim, MD

More Information

Sponsor

Y. Michael Shim, MD

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • hyperpolarized xenon-129 MRI
  • cardiopulmonary stress test
  • lung damage
  • vaping
  • healthy young adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Y. Michael Shim, MD on 2026-03-17.