Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorWestern University, Canada
About this trial
This is a longitudinal study of the long-term health impact of cannabis smoking on the lungs. Participants will be followed over a period of 3 years, and impacts of cannabis 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature
Provision of written, informed consent prior to any study specific procedures
Males and females aged 18-85
Current or former cannabis smoker (medicinal or recreational) with or without concurrent tobacco smoking history
Disqualifiers
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 is medically unstable in the opinion of the Principal Investigator
Participant has a daytime room air oxygen saturation <90% while lying supine
Participant is unable to perform spirometry or plethysmography maneuvers
Trial population
Current and former smokers of cannabis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hyperpolarized Xenon-129 MRI of the lungs
Diagnostic testParticipants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Computed Tomography (CT)
Diagnostic testParticipants will undergo a CT scan of the thoracic cavity
Pulmonary Function Tests (PFTs)
Diagnostic testParticipants will have their lung function evaluated using PFTs
Six Minute Walk Test (6MWT)
Diagnostic testParticipants \>35 years of age will perform the six minute walk test as a measure of exercise capacity
Cardiopulmonary exercise testing (CPET)
Diagnostic testParticipants \<35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
Sputum analysis
Diagnostic testParticipants will provide a sputum sample that will be analysed for eosinophils
Blood analysis
Diagnostic testParticipants will have their blood drawn and analysed for eosinophil count.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Cannabis Smoker7 interventions
Trial outcomes
Primary outcomes
1
Changes in airways over time
Measured using Xenon-129 (129-Xe) MRI
Time frame
3 years2
Changes in parenchyma over time
Measured using Xenon-129 (129-Xe) MRI
Time frame
3 years3
Differences in lung ventilation in cannabis smokers compared to never-smokers and tobacco smokers
Measured using 129-Xe MRI
Time frame
3 years4
Differences in perfusion in cannabis smokers compared to never-smokers and tobacco smokers
Measured using 129-Xe MRI
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov