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129 Xenon MRI in Chronic Lung Disease

Primary Purpose

Lung Disease

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Hyperpolarized Xenon MRI

About this trial

This is an interventional basic science trial for Lung Disease focused on measuring Magnetic Resonance Imaging, Pulmonary Function

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects male and female aged 18-85 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM)
Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
Subject must be able to perform a breathhold for 16s.
Subject is judged to be in otherwise stable health on the basis of medical history
Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume at one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
FEV1 >25% predicted
Forced Vital Capacity (FVC)> 25% predicted and >0.5 liter

Exclusion Criteria:

Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material.
Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine.
Patient is unable to perform spirometry or plethysmography maneuvers
Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
Patient is pregnant or lactating
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.
Subject has an MRI incompatible 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.)

Sites / Locations

Robarts Research Institute; The University of Western Ontario; London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI at baseline and over time

Arm Description

Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.

Outcomes

Primary Outcome Measures

Ventilation Defect Percent (VDP) of the lung

VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity.

Secondary Outcome Measures

Apparent Diffusion Coefficients (ADC) of the lung

Diffusion weighted noble gas MRI provides a way to quantify pulmonary microstructure by sensing the movements of inhaled gas atoms. The "apparent" dif fusion coefficient (ADC) during the diffusion time interval can be used to reflect the extent of alveolar restriction of gas atom movements, providing a surrogate measurement of airspace dimensions.

Dissolved phase spectroscopy measurements

129-Xe dissolved phase MRI data will be reconstructed using a re-gridding method. The following ratios will be determined by the area-under-the curve obtained from spectroscopy: red-blood-cell to alveolar membrane ratio (RBC:membrane); RBC to gas ratio (RBC:gas); and the membrane to gas ratio (membrane:gas). Spectroscopic signals will be used to reconstruct perfusion and alveolar membrane maps.

Full Information

NCT ID

NCT02723500

First Posted

June 24, 2015

Last Updated

May 10, 2023

Sponsor

Western University, Canada

1. Study Identification

Unique Protocol Identification Number

NCT02723500

Brief Title

129 Xenon MRI in Chronic Lung Disease

Official Title

A Study Evaluating Hyperpolarized 129 Xenon Magnetic Resonance Imaging in Subjects With Chronic Lung Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 2011 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University, Canada

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect percent (VDP) and pulmonary gas exchange measurements obtained by analysis of hyperpolarized 129-Xe MRI.

Detailed Description

Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo: brief medical history and vital signs, full pulmonary function tests, proton MRI, spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, Low-dose thoracic CT Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Multiple Breath Nitrogen Washout (MBNW) to measure Lung Clearance Index (LCI), and Forced Oscillation Technique (FOT) will be performed according to American Thoracic Society (ATS) guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, Minnesota USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, Massachusetts USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute. Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one of three 129-Xe chest coils fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation. Thoracic low dose CT will be performed with the same inhalation breath-hold volume and maneuver (nitrogen gas only) used for MRI to obtain participant-specific high resolution images of lung anatomy (tissue structure and airway morphology).

6. Conditions and Keywords

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

Lung Disease

Keywords

Magnetic Resonance Imaging, Pulmonary Function

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

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI at baseline and over time

Arm Type

Other

Arm Description

Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.

Intervention Type

Device

Intervention Name(s)

Hyperpolarized Xenon MRI

Intervention Description

Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.

Primary Outcome Measure Information:

Title

Ventilation Defect Percent (VDP) of the lung

Description

VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Apparent Diffusion Coefficients (ADC) of the lung

Description

Time Frame

5 years

Title

Dissolved phase spectroscopy measurements

Description

Time Frame

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: Subjects male and female aged 18-85 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM) Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent Subject must be able to perform a breathhold for 16s. Subject is judged to be in otherwise stable health on the basis of medical history Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume at one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.) FEV1 >25% predicted Forced Vital Capacity (FVC)> 25% predicted and >0.5 liter Exclusion Criteria: Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material. Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine. Patient is unable to perform spirometry or plethysmography maneuvers Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia. Patient is pregnant or lactating 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. Subject has an MRI incompatible 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.)

Central Contact Person:

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

Grace E Parraga, PhD

Phone

519-931-5265

gparraga@robarts.ca

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

Angela P Wilson, RRT

Phone

519-931-5777

Ext

24197

awilson@robarts.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grace E Parraga, PhD

Organizational Affiliation

Robarts Research Institute, The University of Western Ontario

Official's Role

Principal Investigator

Facility Information:

Facility Name

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5B7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grace E Parraga, PhD

Phone

519-931-5265

gparraga@robarts.ca

12. IPD Sharing Statement

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129 Xenon MRI in Chronic Lung Disease

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