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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03455686
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

McMaster University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Parameswaran Nair, MD, PhD
Principal Investigator Affiliation McMaster University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Asthma, Chronic Obstructive Pulmonary Disease, Bronchiectasis, Emphysema, Pulmonary Fibrosis, Bronchopulmonary Dysplasia, Alpha 1-Antitrypsin Deficiency, Sarcoidosis, Pulmonary
Additional Details

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.

Arms & Interventions

Arms

Experimental: Patients with and without lung disease

All enrolled patients will undergo pulmonary function testing, questionnaires, 1H MRI, static ventilation and/or diffusion-weighted hyperpolarized 129Xe MRI and sputum induction at one or more timepoints over five years.

Interventions

Other: - Hyperpolarized 129Xe MRI

Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas is a research approach for the non-invasive visualization and measurement of lung structure and function.

Contact a Trial Team

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International Sites

Hamilton, Ontario, Canada

Status

Recruiting

Address

Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6

Site Contact

Sarah Svenningsen, PhD

[email protected]

905-522-1155 #37313

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