Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking

Western University, Canada

Status

Enrolling

Conditions

Marijuana Usage

Cannabis Use

Cannabis Smoking

Marijuana Smoking

Treatments

Diagnostic Test: Blood analysis

Diagnostic Test: Six Minute Walk Test (6MWT)

Diagnostic Test: Sputum analysis

Diagnostic Test: Computed Tomography (CT)

Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs

Diagnostic Test: Cardiopulmonary exercise testing (CPET)

Diagnostic Test: Pulmonary Function Tests (PFTs)

Study type

Observational

Funder types

Other

Identifiers

NCT03909477

ROB0043

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.