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Structure and Function MRI of Asthma

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

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 30, 2015
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Structure and Function MRI of Asthma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Asthma
Intervention  ICMJE 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  ICMJE 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02351141
Other Study ID Numbers  ICMJE ROB0037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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  ICMJE Dr. Grace Parraga
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario
PRS Account Western University, Canada
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP