- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909477
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
Study Overview
Status
Intervention / Treatment
- Diagnostic test: Hyperpolarized Xenon-129 MRI of the lungs
- Diagnostic test: Computed Tomography (CT)
- Diagnostic test: Sputum analysis
- Diagnostic test: Blood analysis
- Diagnostic test: Pulmonary Function Tests (PFTs)
- Diagnostic test: Six Minute Walk Test (6MWT)
- Diagnostic test: Cardiopulmonary exercise testing (CPET)
Detailed Description
This is a longitudinal study of the long-term lung health impact of cannabis smoking in adults using xenon-129 (129Xe) MRI over three years.
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).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Angela P Wilson, RRT
- Phone Number: 24197 519-931-5777
- Email: awilson@robarts.ca
Study Contact Backup
- Name: Grace E Parraga, PhD
- Phone Number: 519-931-5265
- Email: gparraga@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5B7
- Recruiting
- Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
-
Contact:
- Grace E Parraga, PhD
- Phone Number: 519-931-5265
- Email: gparraga@uwo.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cannabis Smoker
Participants in this group will be current or former cannabis smokers
|
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
Other Names:
Participants will provide a sputum sample that will be analysed for eosinophils
Participants will have their blood drawn and analysed for eosinophil count.
Participants will have their lung function evaluated using PFTs
Other Names:
Participants >35 years of age will perform the six minute walk test as a measure of exercise capacity
Other Names:
Participants <35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in airways over time
Time Frame: 3 years
|
Measured using Xenon-129 (129-Xe) MRI
|
3 years
|
|
Changes in parenchyma over time
Time Frame: 3 years
|
Measured using Xenon-129 (129-Xe) MRI
|
3 years
|
|
Differences in lung ventilation in cannabis smokers compared to never-smokers and tobacco smokers
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
|
Differences in perfusion in cannabis smokers compared to never-smokers and tobacco smokers
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
|
Differences in parenchyma integrity in cannabis smokers compared to never-smokers and tobacco smokers
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
|
Differences in airways between cannabis-only smokers and cannabis and tobacco smokers
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
|
Differences in parenchyma between cannabis-only smokers and cannabis and tobacco smokers
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
|
Dose-response of cannabis use to changes in airways over time
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
|
Dose-response of cannabis use to changes in parenchyma over time
Time Frame: 3 years
|
Measured using 129-Xe MRI
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Grace E Parraga, PhD, Robarts Research Institute, The University of Western Ontario
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROB0043
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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