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Structure and Function MRI of Asthma

Primary Purpose

Asthma

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Hyperpolarized Noble Gas MRI

About this trial

This is an interventional basic science trial for Asthma focused on measuring Noble Gas MRI, Pulmonary Function, Quality of Life Questionnaires

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects male and female aged 18-60 with a clinical diagnosis of asthma
Smoking history ≤ 1 pack/year
Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
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 FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
FEV1 >60% predicted

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
Patient is unable to perform spirometry or plethysmography maneuvers
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.) (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.
Patient is pregnant

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

Asthma Patients

Arm Description

All enrolled asthma patients will undergo hyperpolarized noble gas MRI with Helium-3 and/or Xenon-129, Pulmonary Function Tests, Quality of Life Questionnaires, dyspnea scales in two visits over three years.

Outcomes

Primary Outcome Measures

Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI

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

Secondary Outcome Measures

Forced Expiratory Volume (FEV1) measured by spirometry

The volume of air that is exhaled in the first second is referred to as FEV1

Additional Pulmonary Function measurements

Measurements include Functional Residual Capacity (FRC); Total Lung Capacity (TLC); Inspiratory Capacity (IC); Airway Resistance (Raw); Forced Vital Capacity (FVC); FEV1/FVC Ratio

Quality of Life questionnaires

questionnaires

Dyspnea Scale

Scale

Full Information

NCT ID

NCT02351141

First Posted

January 15, 2015

Last Updated

May 10, 2023

Sponsor

Dr. Grace Parraga

1. Study Identification

Unique Protocol Identification Number

NCT02351141

Brief Title

Structure and Function MRI of Asthma

Official Title

Structure and Function MRI of Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2015 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Grace Parraga

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in 200 asthma patient volunteers in order to characterize and probe the relationship between lung structure and function using imaging.

Detailed Description

This is an exploratory, longitudinal study with no medication evaluated. 200 asthma patients will visit the Clinical Imaging Research Laboratories at Robarts Research Institute two times over three years: at baseline, and at three years. For the first 60 subjects there will be 3 additional visits - two visits within 4 weeks of baseline (BL+2 weeks; BL+4 weeks; BL+78 weeks) in order to help generate reproducibility data and temporal maps. For all subjects, the Baseline visit will include 129Xe and/or 3He MRI, chest CT, sputum induction, Pulmonary Function Tests, Airwave Oscillation test, Lung Clearance Index test, BORG Dyspnea Scale, and MRC Dyspnea Scale. All procedures will be before, during and after methacholine challenge (MCh). For V2, all but CT and MCh will be acquired. Visits 1a and 1b will include MRI, Pulmonary Function Tests including Airwave Oscillation and Lung Clearance Index, and dyspnea questionnaires; Visit 1c will also include sputum induction. There will be a telephone call at 52+/- 2 weeks, and 104 +/- 2 weeks. to track exacerbations and update medications. Subjects will complete self-assessments in the form of a) the Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S)) bi-weekly, and the Asthma Control Diary (weekly) between visits. Self-reported data (the weekly asthma control diary and bi-weekly AQLQ(S)) will be uploaded by each subject monthly to the investigators website using a confidential and password protected upload (www.imaging.robarts.ca/~gep/ForPatients.htm).

6. Conditions and Keywords

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

Asthma

Keywords

Noble Gas MRI, Pulmonary Function, Quality of Life Questionnaires

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

Asthma Patients

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Hyperpolarized Noble Gas MRI

Intervention Description

Hyperpolarized Helium-3 and/or Xenon-129. Noble gas 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. Noble gas MRI provides a complimentary and alternative method for evaluating lung disease 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 as measured by Xenon-129 and/or Helium-3 MRI

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

Secondary Outcome Measure Information:

Title

Forced Expiratory Volume (FEV1) measured by spirometry

Description

The volume of air that is exhaled in the first second is referred to as FEV1

Time Frame

3 years

Title

Additional Pulmonary Function measurements

Description

Measurements include Functional Residual Capacity (FRC); Total Lung Capacity (TLC); Inspiratory Capacity (IC); Airway Resistance (Raw); Forced Vital Capacity (FVC); FEV1/FVC Ratio

Time Frame

3 years

Title

Quality of Life questionnaires

Description

questionnaires

Time Frame

3 years

Title

Dyspnea Scale

Description

Scale

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects male and female aged 18-60 with a clinical diagnosis of asthma Smoking history ≤ 1 pack/year Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent 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 FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.) FEV1 >60% predicted 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 Patient is unable to perform spirometry or plethysmography maneuvers 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.) (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. Patient is pregnant

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

First Name & Middle Initial & Last Name & Degree

Angela P Wilson, RRT

Phone

519-931-5777

Ext

24197

awilson@robarts.ca

12. IPD Sharing Statement

Citations:

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

31895987

Citation

Eddy RL, Svenningsen S, Kirby M, Knipping D, McCormack DG, Licskai C, Nair P, Parraga G. Is Computed Tomography Airway Count Related to Asthma Severity and Airway Structure and Function? Am J Respir Crit Care Med. 2020 Apr 15;201(8):923-933. doi: 10.1164/rccm.201908-1552OC.

Results Reference

derived

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Structure and Function MRI of Asthma

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