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

NCT06856525 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 230348Pro00116167
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  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).

  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

  Cardiopulmonary stress test maximum oxygen uptake

  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

  Pulmonary Function Test with 6 minute walk test

  Baseline and 12 months follow up

Secondary Outcomes (1)

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

  baseline and 12 months follow-up

Study Arms (2)

Healthy Participants

OTHER

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

Drug: Hyperpolarized xenon 129; Diagnostic Test: Cardiopulmonary Stress Test; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Chest CT

eCig user

EXPERIMENTAL

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

Drug: Hyperpolarized xenon 129; Diagnostic Test: Cardiopulmonary Stress Test; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Chest CT

Interventions

Chest CT DIAGNOSTIC_TEST

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

Healthy Participants; eCig user

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.

Also known as: 129HxeMRI

Healthy Participants; eCig user

Cardiopulmonary Stress Test DIAGNOSTIC_TEST

Exercise stress test to evaluate cardiac and pulmonary fitness.

Also known as: CPET

Healthy Participants; eCig user

Pulmonary Function Test DIAGNOSTIC_TEST

Standard clinic pulmonary function test to evaluate lung function

Also known as: PFT

Healthy Participants; eCig user

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Y. Michael Shim, MD: lead
• Duke University: collaborator
• George Mason University: collaborator

Study Sites (2)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Interventions

Exercise Test; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Yun M Shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roselove Asare, MA

CONTACT

4342436074; rnn3b@virginia.edu

Caleigh Smith, BS

CONTACT

434-243-1140; RJT3QF@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 40 Participants who are healthy with less than 6 months of smoking history and 40 electronic cigarette users with more than 6 months of electronic cigarette usage. Subjects will be recruited and consented at the University of Virginia and Duke University.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: March 4, 2025
• Study Start: December 19, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)