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RecruitingAccepts healthy volunteersPhase 2/Phase 3

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

Y. Michael Shim, MD · with Duke University, George Mason University · NCT06856525

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–35 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
80
US sites recruiting
2
Study start
December 19, 2024
Record last updated
March 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Hyperpolarized xenon 129; Cardiopulmonary Stress Test; Pulmonary Function Test; Chest CT

Conditions: Electronic Cigarette Related Lung Damage

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Duke University

    Durham, NC 27705

    Site contact: Cody Blanton, BS · 919-668-7575 · cody.blanton@duke.edu

  • University of Virginia

    Charlottesville, VA 22908

    Site contact: Yun M Shim, MD · 434-924-5210 · yss6n@virginia.edu

Study contacts (from the official record)

  • Roselove Asare, MA · 4342436074 · rnn3b@virginia.edu
  • Caleigh Smith, BS · 434-243-1140 · RJT3QF@uvahealth.org
All smoking & vaping studies in North Carolina →
Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify… (NCT06856525) | Bored Studies