Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorDr. Grace Parraga
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hyperpolarized Helium MRI
Other interventionHyperpolarized helium-3 (3He) 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. Preliminary studies suggest that 3He MRI may be ideally suited for longitudinal COPD research, which is a likely target application of this novel technology. 3He MRI provides a complementary and alternative method for evaluating COPD and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: COPD and Bronchiectasis PatientsOther 1 intervention
Trial outcomes
Primary outcomes
1
Ventilation Defect Percent (VDP)
VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity
Time frame
3 years2
Apparent Diffusion Coefficients (ADC)
Diffusion weighted noble gas MRI provides a way to quantify pulmonary microstructure by sensing the movements of inhaled gas atoms. The "apparent" dif fusion coefficient (ADC) during the diffusion time interval can be used to reflect the extent of alveolar restriction of gas atom movements, providing a surrogate measurement of airspace dimensions.
Time frame
3 yearsSecondary outcomes
1
Six Minute Walk Distance (6MWD)
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time frame
3 years2
St. George's Respiratory Questionnaire (SGRQ)
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
Time frame
3 years3
Spirometry
Spirometry is a common office test used to assess how well your lungs work by measuring how much air you inhale, how much you exhale and how quickly you exhale.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Grace Parraga
Lead sponsor
University of Western Ontario, Canada
Sponsor institution
London Health Sciences Centre
Collaborator
Source ClinicalTrials.gov