Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking
NCT ID: NCT03909477
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-06-01
2030-12-01
Brief Summary
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Detailed Description
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Males and females between the ages of 18 to 85 years with a history of cannabis smoking will be screened, and those who satisfy all inclusion and exclusion criteria will undergo study visits for up to 3 years, with visits every 12 ± 3 months, for a total of up to four study visits. Each study visit will include collection of patient smoking history and vital signs. At Visit 1 and 4, 129-Xe MRI, spirometry, plethysmography for airways resistance (Raw) and lung volumes, forced oscillation technique (FOT) and multiple breath nitrogen washout (MBNW) for the lung clearance index (LCI) will all be performed pre- and post-bronchodilator. Blood will be drawn for blood eosinophil count, and sputum induction will be done to measure sputum eosinophils. A CT will also be done at Robarts Research Institute, or at University Hospital, London Health Sciences Centre next door to Robarts. Visit 2 will be a telephone call to complete questionnaires. Visit 3 will include spirometry and questionnaires only. Participants 35 years of age or older will complete a six minute walk test (6MWT) for the distance walked (6MWD), pre and post oxygen saturation, perceived dyspnea (Modified Borg Scale) and perceived exertion (Borg's rating of perceived exertion). These participants will complete the St. George's Respiratory Questionnaire (SGRQ).
Participants under the age of 35 will complete Cardio Pulmonary Exercise Testing to assess exercise capacity, and the American Thoracic Society Questionnaire (ATSQ).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cannabis Smoker
Participants in this group will be current or former cannabis smokers
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 (PFTs)
Participants will have their lung function evaluated using PFTs
Six Minute Walk Test (6MWT)
Participants \>35 years of age will perform the six minute walk test as a measure of exercise capacity
Cardiopulmonary exercise testing (CPET)
Participants \<35 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.
Interventions
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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 (PFTs)
Participants will have their lung function evaluated using PFTs
Six Minute Walk Test (6MWT)
Participants \>35 years of age will perform the six minute walk test as a measure of exercise capacity
Cardiopulmonary exercise testing (CPET)
Participants \<35 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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Western University, Canada
OTHER
Responsible Party
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Principal Investigators
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Grace E Parraga, PhD
Role: PRINCIPAL_INVESTIGATOR
Robarts Research Institute, The University of Western Ontario
Locations
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Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ROB0043
Identifier Type: -
Identifier Source: org_study_id
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