Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users

NCT ID: NCT06856525

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-06
• Study Completion Date: 2032-12-31

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.

Detailed Description

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.

Conditions

Electronic Cigarette Related Lung Damage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Participants

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

Group Type: OTHER

Hyperpolarized Xe129

Intervention Type: DRUG

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

Intervention Type: DIAGNOSTIC_TEST

Exercise stress test to evaluate cardiac and pulmonary fitness.

Pulmonary Function Test

Intervention Type: DIAGNOSTIC_TEST

Standard clinic pulmonary function test to evaluate lung function

Chest CT

Intervention Type: DIAGNOSTIC_TEST

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

eCig user

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

Group Type: EXPERIMENTAL

Hyperpolarized Xe129

Intervention Type: DRUG

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

Intervention Type: DIAGNOSTIC_TEST

Exercise stress test to evaluate cardiac and pulmonary fitness.

Pulmonary Function Test

Intervention Type: DIAGNOSTIC_TEST

Standard clinic pulmonary function test to evaluate lung function

Chest CT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Hyperpolarized Xe129

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

Intervention Type: DRUG

Cardiopulmonary Stress Test

Exercise stress test to evaluate cardiac and pulmonary fitness.

Intervention Type: DIAGNOSTIC_TEST

Pulmonary Function Test

Standard clinic pulmonary function test to evaluate lung function

Intervention Type: DIAGNOSTIC_TEST

Chest CT

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CPET; PFT

Eligibility Criteria

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. At baseline, normal spirometry with or without bronchodilator, plethysmograph lung volume, carbon monoxide diffusion capacity, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference.

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Exclusion Criteria

1. History of any other lung disease

2. History of brain diseases including stroke 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

9. Significant history of smoking other substances in the past year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

George Mason University

OTHER

Sponsor Role: collaborator

Y. Michael Shim, MD

OTHER

Sponsor Role: lead

Responsible Party

Y. Michael Shim, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yun M Shim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Duke University

Durham, North Carolina, United States

Site Status: NOT_YET_RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roselove Asare, MA

Role: CONTACT

rnn3b@virginia.edu

4342436074

Caleigh Smith, BS

Role: CONTACT

RJT3QF@uvahealth.org

434-243-1140

Facility Contacts

Cody Blanton, BS

Role: primary

cody.blanton@duke.edu

919-668-7575

Yun M Shim, MD

Role: primary

yss6n@virginia.edu

434-924-5210

Roselove N Asare, MA

Role: backup

rnn3b@virginia.edu

434-243-6074

Other Identifiers

230348

Identifier Type: -

Identifier Source: org_study_id