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RecruitingNCT03909477

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Western University, Canada · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

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.

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHyperpolarized Xenon-129 MRI of the lungsParticipants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
DIAGNOSTIC_TESTComputed Tomography (CT)Participants will undergo a CT scan of the thoracic cavity
DIAGNOSTIC_TESTPulmonary Function Tests (PFTs)Participants will have their lung function evaluated using PFTs
DIAGNOSTIC_TESTSix Minute Walk Test (6MWT)Participants \>35 years of age will perform the six minute walk test as a measure of exercise capacity
DIAGNOSTIC_TESTCardiopulmonary exercise testing (CPET)Participants \<35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
DIAGNOSTIC_TESTSputum analysisParticipants will provide a sputum sample that will be analysed for eosinophils
DIAGNOSTIC_TESTBlood analysisParticipants will have their blood drawn and analysed for eosinophil count.

Timeline

Start date
2022-06-01
Primary completion
2030-12-01
Completion
2030-12-01
First posted
2019-04-10
Last updated
2025-08-15

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03909477. Inclusion in this directory is not an endorsement.