Structure and Function MRI of Asthma

NCT02351141 | Recruiting

• 1 other identifier: ROB0037
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Noble Gas MRI; Pulmonary Function; Quality of Life Questionnaires

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (4)

• Forced Expiratory Volume (FEV1) measured by spirometry

  3 years

• Additional Pulmonary Function measurements

  3 years

• Quality of Life questionnaires

  3 years

• Dyspnea Scale

  3 years

Study Arms (1)

Asthma Patients

OTHER

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.

Other: Hyperpolarized Noble Gas MRI

Interventions

Hyperpolarized Noble Gas MRI OTHER

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.

Asthma Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Grace Parraga: lead

Study Sites (1)

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

London, Ontario, N6A 5B7, Canada

RECRUITING

Related Publications (3)

• McIntosh MJ, Kooner HK, Eddy RL, Wilson A, Serajeddini H, Bhalla A, Licskai C, Mackenzie CA, Yamashita C, Parraga G. CT Mucus Score and 129Xe MRI Ventilation Defects After 2.5 Years' Anti-IL-5Ralpha in Eosinophilic Asthma. Chest. 2023 Jul;164(1):27-38. doi: 10.1016/j.chest.2023.02.009. Epub 2023 Feb 11.

  PMID: 36781102 DERIVED

• 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.

  PMID: 33289613 DERIVED

• 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.

  PMID: 31895987 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265; gparraga@robarts.ca

Angela P Wilson, RRT

CONTACT

519-931-5777; awilson@robarts.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CA (1)