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临床试验/NCT03909477
NCT03909477招募中不适用

Longitudinal Study of Xenon-129 MRI Imaging of Effects of Cannabis Smoking on Lung Structure and Function

Western University, Canada1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Changes in parenchyma over time

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Changes in parenchyma over time

时间窗: 3 years

Measured using Xenon-129 (129-Xe) MRI

Changes in airways over time

时间窗: 3 years

Measured using Xenon-129 (129-Xe) MRI

Differences in lung ventilation in cannabis smokers compared to never-smokers and tobacco smokers

时间窗: 3 years

Measured using 129-Xe MRI

Differences in perfusion in cannabis smokers compared to never-smokers and tobacco smokers

时间窗: 3 years

Measured using 129-Xe MRI

Dose-response of cannabis use to changes in parenchyma over time

时间窗: 3 years

Measured using 129-Xe MRI

Differences in parenchyma integrity in cannabis smokers compared to never-smokers and tobacco smokers

时间窗: 3 years

Measured using 129-Xe MRI

Differences in parenchyma between cannabis-only smokers and cannabis and tobacco smokers

时间窗: 3 years

Measured using 129-Xe MRI

Dose-response of cannabis use to changes in airways over time

时间窗: 3 years

Measured using 129-Xe MRI

Differences in airways between cannabis-only smokers and cannabis and tobacco smokers

时间窗: 3 years

Measured using 129-Xe MRI

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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