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

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease, Bronchiectasis

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Hyperpolarized 129Xe MRI

About this trial

This is an interventional basic science trial for Asthma focused on measuring magnetic resonance imaging, hyperpolarized xenon-129, lung function, lung structure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with and without lung disease

Arm Description

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.

Outcomes

Primary Outcome Measures

Ventilation Defect Percent (VDP)

Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images.

Apparent Diffusion Coefficient (ADC)

Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images.

Secondary Outcome Measures

Signal-to-noise ratio (SNR)

Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images.

Full Information

NCT ID

NCT03455686

First Posted

February 28, 2018

Last Updated

September 7, 2022

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

1. Study Identification

Unique Protocol Identification Number

NCT03455686

Brief Title

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

Official Title

Single-centre Study Exploring the Utility of Hyperpolarized 129Xe Magnetic Resonance Imaging in Healthy Volunteers and Patients With Lung Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 19, 2018 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

magnetic resonance imaging, hyperpolarized xenon-129, lung function, lung structure

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with and without lung disease

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Hyperpolarized 129Xe MRI

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ventilation Defect Percent (VDP)

Description

Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images.

Time Frame

1-5 years

Title

Apparent Diffusion Coefficient (ADC)

Description

Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images.

Time Frame

1-5 years

Secondary Outcome Measure Information:

Title

Signal-to-noise ratio (SNR)

Description

Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images.

Time Frame

1-5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Svenningsen, PhD

Phone

(905) 522-1155

Ext

37313

svennins@mcmaster.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Melanie Kjarsgaard, RRT

Phone

(905) 522-1155

Ext

33024

mkjarsga@stjosham.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parameswaran Nair, MD, PhD

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Svenningsen, PhD

Phone

905-522-1155

Ext

37313

svennins@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22104288

Citation

Kirby M, Heydarian M, Svenningsen S, Wheatley A, McCormack DG, Etemad-Rezai R, Parraga G. Hyperpolarized 3He magnetic resonance functional imaging semiautomated segmentation. Acad Radiol. 2012 Feb;19(2):141-52. doi: 10.1016/j.acra.2011.10.007. Epub 2011 Nov 21.

Results Reference

background

PubMed Identifier

23239874

Citation

Kirby M, Svenningsen S, Kanhere N, Owrangi A, Wheatley A, Coxson HO, Santyr GE, Paterson NA, McCormack DG, Parraga G. Pulmonary ventilation visualized using hyperpolarized helium-3 and xenon-129 magnetic resonance imaging: differences in COPD and relationship to emphysema. J Appl Physiol (1985). 2013 Mar 15;114(6):707-15. doi: 10.1152/japplphysiol.01206.2012. Epub 2012 Dec 13.

Results Reference

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PubMed Identifier

21105144

Citation

Fain S, Schiebler ML, McCormack DG, Parraga G. Imaging of lung function using hyperpolarized helium-3 magnetic resonance imaging: Review of current and emerging translational methods and applications. J Magn Reson Imaging. 2010 Dec;32(6):1398-408. doi: 10.1002/jmri.22375.

Results Reference

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PubMed Identifier

26218920

Citation

Kruger SJ, Nagle SK, Couch MJ, Ohno Y, Albert M, Fain SB. Functional imaging of the lungs with gas agents. J Magn Reson Imaging. 2016 Feb;43(2):295-315. doi: 10.1002/jmri.25002. Epub 2015 Jul 27.

Results Reference

background

PubMed Identifier

22591724

Citation

Shukla Y, Wheatley A, Kirby M, Svenningsen S, Farag A, Santyr GE, Paterson NA, McCormack DG, Parraga G. Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Acad Radiol. 2012 Aug;19(8):941-51. doi: 10.1016/j.acra.2012.03.018. Epub 2012 May 15.

Results Reference

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PubMed Identifier

22056683

Citation

Driehuys B, Martinez-Jimenez S, Cleveland ZI, Metz GM, Beaver DM, Nouls JC, Kaushik SS, Firszt R, Willis C, Kelly KT, Wolber J, Kraft M, McAdams HP. Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Radiology. 2012 Jan;262(1):279-89. doi: 10.1148/radiol.11102172. Epub 2011 Nov 4.

Results Reference

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PubMed Identifier

23589465

Citation

Svenningsen S, Kirby M, Starr D, Leary D, Wheatley A, Maksym GN, McCormack DG, Parraga G. Hyperpolarized (3) He and (129) Xe MRI: differences in asthma before bronchodilation. J Magn Reson Imaging. 2013 Dec;38(6):1521-30. doi: 10.1002/jmri.24111. Epub 2013 Apr 15.

Results Reference

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PubMed Identifier

29313707

Citation

Svenningsen S, Eddy RL, Lim HF, Cox PG, Nair P, Parraga G. Sputum Eosinophilia and Magnetic Resonance Imaging Ventilation Heterogeneity in Severe Asthma. Am J Respir Crit Care Med. 2018 Apr 1;197(7):876-884. doi: 10.1164/rccm.201709-1948OC.

Results Reference

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PubMed Identifier

27174885

Citation

Svenningsen S, Nair P, Guo F, McCormack DG, Parraga G. Is ventilation heterogeneity related to asthma control? Eur Respir J. 2016 Aug;48(2):370-9. doi: 10.1183/13993003.00393-2016. Epub 2016 May 12.

Results Reference

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PubMed Identifier

22952383

Citation

Kirby M, Svenningsen S, Owrangi A, Wheatley A, Farag A, Ouriadov A, Santyr GE, Etemad-Rezai R, Coxson HO, McCormack DG, Parraga G. Hyperpolarized 3He and 129Xe MR imaging in healthy volunteers and patients with chronic obstructive pulmonary disease. Radiology. 2012 Nov;265(2):600-10. doi: 10.1148/radiol.12120485. Epub 2012 Sep 5.

Results Reference

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

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