Electronic Cigarette Related Lung DamagePhase 2/3ECigNCT06856525
Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology
A Phase 2/3 study testing Hyperpolarized xenon 129, Cardiopulmonary Stress Test and Pulmonary Function Test in people with Electronic Cigarette Related Lung Damage, run by Y. Michael Shim, MD at 2 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Related Lung Damage
- What is being tested?
- Hyperpolarized xenon 129, Cardiopulmonary Stress Test and Pulmonary Function Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2024to 31 Dec 2032
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
- -
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Yun M Shim, MD, 434-924-5210, yss6n@virginia.edu
Roselove N Asare, MA, 434-243-6074, rnn3b@virginia.edu
- Recruiting
Duke University
Durham, North Carolina, 27705
Cody Blanton, BS, 919-668-7575, cody.blanton@duke.edu
Joseph Mammarappallil, MD
About this study
Official title: Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Healthy Participants and E-cigarette Users
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.
Read the 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
- Being tested
- Hyperpolarized xenon 129, Cardiopulmonary Stress Test, Pulmonary Function Test, Chest CT
- Keywords
- hyperpolarized xenon-129 MRI, cardiopulmonary stress test, lung damage, vaping, healthy young adult
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized xenon 129Drug
Also called 129HxeMRI
Determine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI.
Cardiopulmonary Stress TestDiagnostic test
Also called CPET
Exercise stress test to evaluate cardiac and pulmonary fitness.
Pulmonary Function TestDiagnostic test
Also called PFT
Standard clinic pulmonary function test to evaluate lung function
Chest CTDiagnostic test
Clinical standard chest computer tomography to evaluate any lung tissue scars or air movement.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Other | Young, healthy subjects without any lung disease or other inflammatory diseases. Receives: 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. Receives: Drug: Hyperpolarized xenon 129; Diagnostic Test: Cardiopulmonary Stress Test; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Chest CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: Baseline and 12 months follow up
Secondary outcomes (1)
Acute Effects of eCig use at baseline and 12 months follow-up
blood levels of 32 chemical toxins
Measured: baseline and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start19 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette Related Lung DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Y. Michael Shim, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, George Mason University
- Responsible party
- Sponsor-investigator, Y. Michael Shim, MD, University of Virginia
- Investigators
- Yun M Shim, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856525
- Sponsor's protocol ID
- 230348
- Other IDs
- Pro00116167
- Acronym
- ECig
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As a part of publications.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Healthy Participants and E-cigarette Users
- ClinicalTrials.gov ID
- NCT06856525
- Acronym / sponsor ID
- ECig / 230348
- Conditions
- Electronic Cigarette Related Lung Damage
- Keywords
- hyperpolarized xenon-129 MRI, cardiopulmonary stress test, lung damage, vaping, healthy young adult
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Y. Michael Shim, MDUniversity, hospital or other
- Collaborators
- Duke University, George Mason University
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Other | Drug: Hyperpolarized xenon 129, Diagnostic Test: Cardiopulmonary Stress Test, Diagnostic Test: Pulmonary Function Test, Diagnostic Test: Chest CTYoung, healthy subjects without any lung disease or other inflammatory diseases. |
| eCig user | Experimental | Drug: Hyperpolarized xenon 129, Diagnostic Test: Cardiopulmonary Stress Test, Diagnostic Test: Pulmonary Function Test, Diagnostic Test: Chest CTYoung, otherwise healthy subjects who have used electronic cigarettes for at least 6 months past year. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized xenon 129Also: 129HxeMRIDetermine the impact of e-cigarette use on pulmonary gas exchange capacity in interstitial tissues and capillaries using hyperpolarized xenon-129 MRI. | Drug | Healthy Participants, eCig user |
| Cardiopulmonary Stress TestAlso: CPETExercise stress test to evaluate cardiac and pulmonary fitness. | Diagnostic test | Healthy Participants, eCig user |
| Pulmonary Function TestAlso: PFTStandard clinic pulmonary function test to evaluate lung function | Diagnostic test | Healthy Participants, eCig user |
| Chest CTClinical standard chest computer tomography to evaluate any lung tissue scars or air movement. | Diagnostic test | Healthy Participants, eCig user |
Primary outcome
Comparison between e-cig user vs. healthy participants at baseline and 12 month later
Time frame: baseline and 12 month follow-up
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).
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
Cardiopulmonary stress test maximum oxygen uptake
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
Pulmonary Function Test with 6 minute walk test
1 secondary outcome
Acute Effects of eCig use at baseline and 12 months follow-up
Time frame: baseline and 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. As a part of publications.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun M Shim, MD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyperpolarized xenon 129, Cardiopulmonary Stress Test and Pulmonary Function Test in people with Electronic Cigarette Related Lung Damage, run by Y. Michael Shim, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roselove Asare, MA (4342436074, rnn3b@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.