Recruiting

Pulmonary Imaging

Sponsor:

Western University, Canada

Code:

NCT04616313

Conditions

E Cigarette Use

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized Xenon-129 MRI of the lungs

Computed Tomography (CT)

Pulmonary Function Tests (PFT)

Cardiopulmonary exercise testing (CPET)

Sputum analysis

Study Details

Brief summary:

This is a longitudinal study of the long-term health impact of e-cigarette smoking on the lungs. Participants will be followed over a period of 5 years, and impacts of e-cigarette smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.

Conditions

E Cigarette Use

Study ID

NCT04616313

Start date

Jan 17, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Written informed consent must be directly obtained from legally competent participants before any study-related assessment is performed.
  • Male and female participant age ≥16 years.
  • Participant has recently started vaping, >1 and <5 years weekly use.
  • 70 participants will be c-cigarette never users.
  • 70 participants will be former or current c-cigarette users.
  • 10 asymptomatic age and sex-matched healthy people who have never used e- or c-cigarettes will be controls.

Exclusion Criteria:

  • Participants with contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
  • Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material.
  • Participant unable to perform spirometry or plethysmography maneuvers.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

c-cigarette never users

Includes 70 participants who are e-cigarette users who have never smoked combustible cigarettes.

former or current c-cigarette users

Includes 70 participants who are e-cigarette users who are also former or current combustible cigarette smokers.

never smokers

Includes 10 participants who have never smoked e-cigarettes or combustible cigarettes.

Interventions

Hyperpolarized Xenon-129 MRI of the lungs

Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas

Computed Tomography (CT)

Participants will undergo a CT scan of the thoracic cavity

Pulmonary Function Tests (PFT)

Participants will have their lung function evaluated using PFT

Cardiopulmonary exercise testing (CPET)

Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity

Sputum analysis

Participants will provide a sputum sample that will be analysed for eosinophils

Blood analysis

Participants will have their blood drawn and analysed for eosinophil count.

Questionnaires

Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.

Primary outcome measure

  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report pulmonary imaging abnormalities. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FEV1. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FVC. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by TLC. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FRC. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by RV. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FOT. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by LCI. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by FeNO. [ Time Frame: 12 weeks following enrollment ]
  • Determine if e-cigarette users who did not require hospitalization, nor used c-cigarettes report respiratory symptoms or abnormal pulmonary function measured by exercise capacity [ Time Frame: 12 weeks following enrollment ]

Central Contacts and Locations

Central contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

Angela Wilson, RRT

519-931-5777awilson@robarts.ca

Locations

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Grace E Parraga, PhD

519-931-5265gparraga@uwo.ca

More Information

Sponsor

Western University, Canada

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • e-cigarette smoking
  • pulmonary function
  • Xenon-129
  • Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2025-08-14.