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Structure and Function MRI of Asthma

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ClinicalTrials.gov Identifier: NCT02351141
Recruitment Status : Recruiting
First Posted : January 30, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Grace Parraga, University of Western Ontario, Canada

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.

Condition or disease Intervention/treatment Phase
Asthma Other: Hyperpolarized Noble Gas MRI Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Structure and Function MRI of Asthma
Actual Study Start Date : January 2015
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.
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.





Primary Outcome Measures :
  1. Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Forced Expiratory Volume (FEV1) measured by spirometry [ Time Frame: 3 years ]
  2. 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

  3. Quality of Life questionnaires [ Time Frame: 3 years ]
    questionnaires

  4. Dyspnea Scale [ Time Frame: 3 years ]
    Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351141


Contacts
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Contact: Grace E Parraga, PhD 519-931-5265 gparraga@robarts.ca
Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 lreid@robarts.ca

Locations
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Canada, Ontario
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5B7
Contact: Grace E Parraga, PhD    519-931-5265    gparraga@robarts.ca   
Contact: Lyndsey A Reid-Jones, RPN    519-931-5777 ext 24197    lreid@robarts.ca   
Sponsors and Collaborators
Dr. Grace Parraga
Investigators
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Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario

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Responsible Party: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT02351141     History of Changes
Other Study ID Numbers: ROB0037
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Keywords provided by Dr. Grace Parraga, University of Western Ontario, Canada:
Noble Gas MRI
Pulmonary Function
Quality of Life Questionnaires

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases