Who is eligible for clinical trial NCT06856525?

Participants must meet protocol criteria for Electronic Cigarette Related Lung Damage. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06856525 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-14

Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology (NCT06856525)

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Y. Michael Shim, MD

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).

Location: Duke University — Durham, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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) \-

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Duke University — Durham, North Carolina
University of Virginia — Charlottesville, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗