Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging

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Brief Title

Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging

Official Title

Longitudinal Study of 3He and 129Xe Magnetic Resonance Imaging in Chronic Obstructive Pulmonary Disease

Brief Summary

      Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive
      pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history
      will be imaged with CT and MRI for the development of tools to quantify and validate
      longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.
    

Detailed Description

      COPD patients will be stratified into four groups: Gold Stage 0, Gold Stage I, Gold Stage II,
      and Gold Stage III. During a single 2-2 ½ hour visit, patient subjects will perform some or
      all of: 1) spirometry pre-and-post salbutamol and plethysmography, Lung Clearance Index,
      Airway Oscillometry (Airwave Oscillometry measures the mechanics of the respiratory system by
      superimposing a gentle multi-frequency airwave onto the patient's respiratory airflow.
      Measurements take no longer than 16 seconds and the patient simply breathes normally into a
      disposable mouthpiece for the duration of the test.) 2) 6MWT (including Borg questionnaire
      pre-and post-walk), 3) health status evaluation using a self-administered SGRQ and MMRC
      (Modified Medical Research Council dyspnea scale) 4) CT, and, 5) 3He MRI.

      Subjects will first provide written informed consent and then be screened for MRI
      compatibility and will complete: 1) Spirometry pre-salbutamol, SGRQ after inhaling 2-4 puffs
      (200-400μg) of the short-acting bronchodilator (eg. Salbutamol), 2) MRI, 3) CT. (Subjects
      will be taken by wheelchair to and from University Hospital, LHSC to decrease the potential
      for dynamic hyperinflation), 4) plethysmography and spirometry within 1 ½ hours of
      salbutamol. Vital signs will be performed. Because it is impossible to schedule imaging at
      the same time-point post-bronchodilator, subjects will be randomized to MR or CT 30 minutes
      post-salbutamol (1:1 ratio), to minimize bias.
    


Study Type

Interventional


Primary Outcome

Ventilation Defect Percent (VDP)

Secondary Outcome

 Six Minute Walk Distance (6MWD)

Condition

COPD

Intervention

Hyperpolarized Helium MRI

Study Arms / Comparison Groups

 COPD and Bronchiectasis Patients
Description:  All enrolled COPD and Bronchiectasis patients will undergo Pulmonary Function Tests, Hyperpolarized Helium MRI, chest CT, 6-Minute Walk Test, and complete questionnaires at up to 8 visits over 2-3 years.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

200

Start Date

May 2009

Completion Date

March 2022

Primary Completion Date

March 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects male and female aged 50-85 with either A) a clinical diagnosis of COPD or
             Bronchiectais or B) >10 pack/year smoking history

          -  Subject understands the study procedures and is willing to participate in the study as
             indicated by signature on the informed consent

          -  Subject must be able to perform a breathhold for 16s.

          -  Subject is judged to be in otherwise stable health on the basis of medical history

          -  Subject is ambulatory and can perform the 6MWT

          -  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 >25% predicted

          -  FVC > 25% predicted and >0.5L

        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.

          -  Subject has a daytime room air oxygen saturation <90% while lying supine.

          -  Patient is unable to perform spirometry or plethysmography maneuvers

          -  Patient is pregnant

          -  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.

          -  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.)
      

Gender

All

Ages

50 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Grace E Parraga, PhD, 519-931-5265, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02279329

Organization ID

ROB0018


Responsible Party

Sponsor-Investigator

Study Sponsor

Dr. Grace Parraga

Collaborators

 London Health Sciences Centre

Study Sponsor

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


Verification Date

September 2019