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Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging

Primary Purpose

COPD, Bronchiectasis

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Hyperpolarized Helium MRI

About this trial

This is an interventional basic science trial for COPD

Eligibility Criteria

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

Inclusion Criteria:

Subjects male and female aged 50-85 with either A) a clinical diagnosis of COPD or Bronchiectais or B) >10 pack/year smoking history
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 is ambulatory and can perform the 6MWT
Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
FEV1 >25% predicted
FVC > 25% predicted and >0.5L

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 <90% while lying supine.
Patient is unable to perform spirometry or plethysmography maneuvers
Patient is pregnant
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 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.)

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

COPD and Bronchiectasis Patients

Arm Description

All enrolled COPD and Bronchiectasis patients will undergo Pulmonary Function Tests, Hyperpolarized Helium MRI, chest CT, 6-Minute Walk Test, and complete questionnaires at up to 8 visits over 2-3 years.

Outcomes

Primary Outcome Measures

Ventilation Defect Percent (VDP)

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

Apparent Diffusion Coefficients (ADC)

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.

Secondary Outcome Measures

Six Minute Walk Distance (6MWD)

The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

St. George's Respiratory Questionnaire (SGRQ)

Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

Spirometry

Spirometry is a common office test used to assess how well your lungs work by measuring how much air you inhale, how much you exhale and how quickly you exhale.

Full Information

NCT ID

NCT02279329

First Posted

October 24, 2014

Last Updated

May 10, 2023

Sponsor

Dr. Grace Parraga

Collaborators

London Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT02279329

Brief Title

Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging

Official Title

Longitudinal Study of 3He and 129Xe Magnetic Resonance Imaging in Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2009 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Grace Parraga

Collaborators

London Health Sciences Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history will be imaged with CT and MRI for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.

Detailed Description

COPD patients will be stratified into four groups: Gold Stage 0, Gold Stage I, Gold Stage II, and Gold Stage III. During a single 2-2 ½ hour visit, patient subjects will perform some or all of: 1) spirometry pre-and-post salbutamol and plethysmography, Lung Clearance Index, Airway Oscillometry (Airwave Oscillometry measures the mechanics of the respiratory system by superimposing a gentle multi-frequency airwave onto the patient's respiratory airflow. Measurements take no longer than 16 seconds and the patient simply breathes normally into a disposable mouthpiece for the duration of the test.) 2) 6MWT (including Borg questionnaire pre-and post-walk), 3) health status evaluation using a self-administered SGRQ and MMRC (Modified Medical Research Council dyspnea scale) 4) CT, and, 5) 3He MRI. Subjects will first provide written informed consent and then be screened for MRI compatibility and will complete: 1) Spirometry pre-salbutamol, SGRQ after inhaling 2-4 puffs (200-400μg) of the short-acting bronchodilator (eg. Salbutamol), 2) MRI, 3) CT. (Subjects will be taken by wheelchair to and from University Hospital, LHSC to decrease the potential for dynamic hyperinflation), 4) plethysmography and spirometry within 1 ½ hours of salbutamol. Vital signs will be performed. Because it is impossible to schedule imaging at the same time-point post-bronchodilator, subjects will be randomized to MR or CT 30 minutes post-salbutamol (1:1 ratio), to minimize bias.

6. Conditions and Keywords

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

COPD, Bronchiectasis

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

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD and Bronchiectasis Patients

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Hyperpolarized Helium MRI

Intervention Description

Hyperpolarized helium-3 (3He) magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces. Preliminary studies suggest that 3He MRI may be ideally suited for longitudinal COPD research, which is a likely target application of this novel technology. 3He MRI provides a complementary and alternative method for evaluating COPD and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.

Primary Outcome Measure Information:

Title

Ventilation Defect Percent (VDP)

Description

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

Time Frame

3 years

Title

Apparent Diffusion Coefficients (ADC)

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Six Minute Walk Distance (6MWD)

Description

The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

Time Frame

3 years

Title

St. George's Respiratory Questionnaire (SGRQ)

Description

Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

Time Frame

3 years

Title

Spirometry

Description

Spirometry is a common office test used to assess how well your lungs work by measuring how much air you inhale, how much you exhale and how quickly you exhale.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects male and female aged 50-85 with either A) a clinical diagnosis of COPD or Bronchiectais or B) >10 pack/year smoking history 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 is ambulatory and can perform the 6MWT Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.) FEV1 >25% predicted FVC > 25% predicted and >0.5L 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 <90% while lying supine. Patient is unable to perform spirometry or plethysmography maneuvers Patient is pregnant 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 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.)

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

Citations:

PubMed Identifier

11756734

Citation

Salerno M, de Lange EE, Altes TA, Truwit JD, Brookeman JR, Mugler JP 3rd. Emphysema: hyperpolarized helium 3 diffusion MR imaging of the lungs compared with spirometric indexes--initial experience. Radiology. 2002 Jan;222(1):252-60. doi: 10.1148/radiol.2221001834.

Results Reference

background

PubMed Identifier

17968961

Citation

Evans A, McCormack D, Ouriadov A, Etemad-Rezai R, Santyr G, Parraga G. Anatomical distribution of 3He apparent diffusion coefficients in severe chronic obstructive pulmonary disease. J Magn Reson Imaging. 2007 Dec;26(6):1537-47. doi: 10.1002/jmri.21205.

Results Reference

background

PubMed Identifier

18790402

Citation

Mathew L, Evans A, Ouriadov A, Etemad-Rezai R, Fogel R, Santyr G, McCormack DG, Parraga G. Hyperpolarized 3He magnetic resonance imaging of chronic obstructive pulmonary disease: reproducibility at 3.0 tesla. Acad Radiol. 2008 Oct;15(10):1298-311. doi: 10.1016/j.acra.2008.04.019.

Results Reference

background

PubMed Identifier

33289613

Citation

Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.

Results Reference

derived

PubMed Identifier

32096708

Citation

MacNeil JL, Capaldi DPI, Westcott AR, Eddy RL, Barker AL, McCormack DG, Kirby M, Parraga G. Pulmonary Imaging Phenotypes of Chronic Obstructive Pulmonary Disease Using Multiparametric Response Maps. Radiology. 2020 Apr;295(1):227-236. doi: 10.1148/radiol.2020191735. Epub 2020 Feb 25.

Results Reference

derived

Learn more about this trial

Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging

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