Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease

  • STATUS
    Recruiting
  • End date
    Mar 14, 2023
  • participants needed
    60
  • sponsor
    McMaster University
Updated on 7 October 2022
COPD
deficiency
respiratory infection
chronic obstructive pulmonary disease
pulmonary disease
pulmonary fibrosis
dysplasia
malnourished
malnutrition
asthma
lung disease
fibrosis
emphysema
sarcoidosis, pulmonary
bronchiectasis
sarcoidosis
trypsin
bronchopulmonary dysplasia
Accepts healthy volunteers

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 disease to better understand lung structure and function and evaluate response to therapy delivered as a part of clinical care.

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 hyperpolarized 129Xe MRI at one or more time-points (over time in the absence of therapeutic intervention or following clinically indicated therapy) in healthy volunteers and patients with 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.

This will be a single centre exploratory study in 10 healthy volunteers with normal lung function and no history of lung disease and 50 patients with a clinical diagnosis of lung disease. There is one study visit required for participation. A subset of participants may be asked to return for up to five additional study visits per year for five years. The purpose of additional study visits is to understand how hyperpolarized 129Xe MRI measurements of lung structure and function change over time in the absence of therapeutic intervention or following clinically indicated therapy.

All subjects will visit St Joseph's Healthcare Hamilton and undergo: vital signs, pulmonary function testing, questionnaires, proton (1H) MRI, static ventilation and/or diffusion-weighted 129Xe MRI, and sputum induction. Up to four doses of hyperpolarized 129Xe will be inhaled during a single study visit.

Details
Condition Asthma, Chronic Obstructive Pulmonary Disease, Bronchiectasis, Emphysema, Pulmonary Fibrosis, Bronchopulmonary Dysplasia, Alpha 1-Antitrypsin Deficiency, Sarcoidosis, Pulmonary
Treatment Hyperpolarized 129Xe MRI
Clinical Study IdentifierNCT03455686
SponsorMcMaster University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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