Structure and Function MRI of Asthma

• ClinicalTrials.gov Identifier: NCT02351141
• Recruitment Status: Unknown
• First Posted: January 30, 2015
• Last Update Posted: October 2, 2019
• Sponsor: Dr. Grace Parraga
• Information provided by (Responsible Party): Dr. Grace Parraga, University of Western Ontario, Canada

Tracking Information

• First Submitted Date: January 15, 2015
• First Posted Date: January 30, 2015
• Last Update Posted Date: October 2, 2019
• Actual Study Start Date: January 2015
• Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 26, 2015): Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2015)

• Forced Expiratory Volume (FEV1) measured by spirometry [ Time Frame: 3 years ]
• Additional Pulmonary Function measurements [ Time Frame: 3 years ]
  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 [ Time Frame: 3 years ]
  questionnaires
• Dyspnea Scale [ Time Frame: 3 years ]
  Scale

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Structure and Function MRI of Asthma
• Official Title: Structure and Function MRI of Asthma
• Brief Summary: The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in 120 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. 120 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).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Asthma

Intervention

Other: Hyperpolarized Noble Gas MRI

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.

Study Arms

Asthma Patients

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.

Intervention: Other: Hyperpolarized Noble Gas MRI

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 26, 2015): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2022
• Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02351141
• Other Study ID Numbers: ROB0037
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr. Grace Parraga, University of Western Ontario, Canada
• Original Responsible Party: Dr. Grace Parraga, Western University, Canada, PhD, Scientist. Robarts Research Institute
• Current Study Sponsor: Dr. Grace Parraga
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Grace E Parraga, PhD; Robarts Research Institute, The University of Western Ontario

• PRS Account: Western University, Canada
• Verification Date: September 2019