Status:
RECRUITING
Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Conditions:
Asthma
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in individual patients with and without lung dis...
Detailed Description
The primary objective of this study is to evaluate the ventilation defect percent (VDP), apparent diffusion coefficient (ADC) and/or the signal-to-noise ratio (SNR) obtained by analysis of hyperpolari...
Eligibility Criteria
Inclusion
- Inclusion Criteria for participants with lung disease:
- Male or female aged 18-85 years with diagnosed lung disease including but not limited to: asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, eosinophilic granulomatosis with polyangiitis and bronchopulmonary dysplasia.
- Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
- Subject is judged to be in otherwise stable health on the basis of medical history
- Able to read and/or understand English
- Have a diagnosis of lung disease
- Inclusion Criteria for healthy volunteers:
- Subjects male or female aged 18-85 years
- Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
- Subject is judged to be in otherwise stable health on the basis of medical history
- Able to read and/or understand English
- No current or previous history of respiratory infection or disease
- Exclusion Criteria:
- Age \< 18 years or \>85 years
- Pregnancy prior to or during study
- In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Patient is unable to perform spirometry or plethysmography maneuvers
- Patient has an 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/3T Manager)
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
- Exclusion Criteria for healthy volunteers only:
- Current or previous history of respiratory infection or disease
- Current smoker or ex-smoker with ≥10 pack-year history
Exclusion
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03455686
Start Date
April 19 2018
End Date
December 1 2024
Last Update
May 21 2024
Active Locations (1)
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1
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6