Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking
Longitudinal Study of Xenon-129 MRI Imaging of Effects of Cannabis Smoking on Lung Structure and Function
Western University, Canada
200 participants
Jun 1, 2022
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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
- Participant is able to perform reproducible pulmonary function testing (i.e. the 3 best acceptable spirograms have Forced Expiratory Volume in 1 second (FEV1) values that do not vary more than 150 millilitres)
- Participant is able to perform a breathhold for 16s
- FEV1 \> 25% predicted
- Forced Vital Capacity (FVC) \> 25% predicted and \>0.5 litres
Exclusion Criteria7
- 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
- Patient is pregnant at time of enrolment
- In the opinion of the investigator, patient suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
- Patient has implanted mechanically, electrically or magnetically activated device or any metal in their body, which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) - at the discretion of the MRI Technologist.
Interventions
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Participants will undergo a CT scan of the thoracic cavity
Participants will have their lung function evaluated using PFTs
Participants \>35 years of age will perform the six minute walk test as a measure of exercise capacity
Participants \<35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
Participants will provide a sputum sample that will be analysed for eosinophils
Participants will have their blood drawn and analysed for eosinophil count.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03909477