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

Last updated: June 12, 2024
Sponsor: Western University, Canada
Overall Status: Active - Recruiting

Phase

N/A

Condition

Substance Abuse

Treatment

Six Minute Walk Test (6MWT)

Hyperpolarized Xenon-129 MRI of the lungs

Cardiopulmonary exercise testing (CPET)

Clinical Study ID

NCT03909477
ROB0043
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patient understands study procedures and is willing to participate in the study asindicated 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 withoutconcurrent tobacco smoking history

  • Participant is able to perform reproducible pulmonary function testing (i.e. the 3best acceptable spirograms have Forced Expiratory Volume in 1 second (FEV1) valuesthat 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

Exclusion Criteria:

  • Participant is, in the opinion of the investigator, mentally or legallyincapacitated, preventing informed consent from being obtained, or cannot read orunderstand 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, psychologicalor other condition(s) that might prevent performance of the MRI, such as severeclaustrophobia

  • Patient has implanted mechanically, electrically or magnetically activated device orany metal in their body, which cannot be removed, including but not limited topacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysmclips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt,surgical staples (including clips or metallic sutures and/or ear implants) - at thediscretion of the MRI Technologist.

Study Design

Total Participants: 200
Treatment Group(s): 7
Primary Treatment: Six Minute Walk Test (6MWT)
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
December 01, 2030

Study 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).

Connect with a study center

  • Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre

    London, Ontario N6A 5B7
    Canada

    Site Not Available

  • Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

    London, Ontario N6A 5B7
    Canada

    Active - Recruiting

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