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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: Hyperpolarized Noble Gas MRI||Not Applicable|
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 (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|
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.
- Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI [ Time Frame: 3 years ]
- 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
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
|Contact: Grace E Parraga, PhDemail@example.com|
|Contact: Lyndsey A Reid-Jones, RPN||519-931-5777 ext firstname.lastname@example.org|
|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 email@example.com|
|Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 firstname.lastname@example.org|
|Principal Investigator:||Grace E Parraga, PhD||Robarts Research Institute, The University of Western Ontario|