COPDNCT02279329
Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging
A study testing Hyperpolarized Helium MRI in people with COPD and Bronchiectasis, run by Dr. Grace Parraga at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- COPD, Bronchiectasis
- What is being tested?
- Hyperpolarized Helium MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7
Grace E Parraga, PhD, 519-931-5265, gparraga@robarts.ca
About this study
Official title: Longitudinal Study of 3He and 129Xe Magnetic Resonance Imaging in Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- COPD, Bronchiectasis
- Being tested
- Hyperpolarized Helium MRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Helium MRIOther
Hyperpolarized 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD and Bronchiectasis Patients | Other | 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. Receives: Other: Hyperpolarized Helium MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
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.
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMay 2009
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Grace Parraga
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor-investigator, Dr. Grace Parraga, University of Western Ontario, Canada
- Investigators
- Grace E Parraga, PhD, Principal investigator, Robarts Research Institute, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279329
- Sponsor's protocol ID
- ROB0018
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2014
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Salerno M, de Lange EE, Altes TA, Truwit JD, Brookeman JR, Mugler JP 3rd. Emphysema: hyperpolarized helium 3 diffusion MR imaging of the lungs compared with spirometric indexes--initial experience. Radiology. 2002 Jan;222(1):252-60. doi: 10.1148/radiol.2221001834.
PubMed 11756734Evans A, McCormack D, Ouriadov A, Etemad-Rezai R, Santyr G, Parraga G. Anatomical distribution of 3He apparent diffusion coefficients in severe chronic obstructive pulmonary disease. J Magn Reson Imaging. 2007 Dec;26(6):1537-47. doi: 10.1002/jmri.21205.
PubMed 17968961Mathew L, Evans A, Ouriadov A, Etemad-Rezai R, Fogel R, Santyr G, McCormack DG, Parraga G. Hyperpolarized 3He magnetic resonance imaging of chronic obstructive pulmonary disease: reproducibility at 3.0 tesla. Acad Radiol. 2008 Oct;15(10):1298-311. doi: 10.1016/j.acra.2008.04.019.
PubMed 18790402Tcherner S, Durom E, Peters J, Gater O, Parraga G. Airway Mucus Occlusions in Ex-Smokers with and Without COPD. COPD. 2026 Dec;23(1):2681969. doi: 10.1080/15412555.2026.2681969. Epub 2026 Jun 16.
PubMed 42301257Kooner HK, Wyszkiewicz PV, Matheson AM, McIntosh MJ, Abdelrazek M, Dhaliwal I, Nicholson JM, Kirby M, Svenningsen S, Parraga G. Chest CT Airway and Vascular Measurements in Females with COPD or Long-COVID. COPD. 2024 Dec;21(1):2394129. doi: 10.1080/15412555.2024.2394129. Epub 2024 Sep 2.
PubMed 39221567Sharma M, Wyszkiewicz PV, Matheson AM, McCormack DG, Parraga G. Chest MRI and CT Predictors of 10-Year All-Cause Mortality in COPD. COPD. 2023 Dec;20(1):307-320. doi: 10.1080/15412555.2023.2259224. Epub 2023 Sep 22.
PubMed 37737132Wyszkiewicz PV, Sharma M, Desaigoudar V, Cunningham IA, McCormack DG, Abdelrazek MA, Kirby M, Parraga G. Reduced Total Airway Count and Airway Wall Tapering after Three-Years in Ex-Smokers. COPD. 2023 Dec;20(1):186-196. doi: 10.1080/15412555.2023.2222831.
PubMed 37395048Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.
PubMed 33289613MacNeil JL, Capaldi DPI, Westcott AR, Eddy RL, Barker AL, McCormack DG, Kirby M, Parraga G. Pulmonary Imaging Phenotypes of Chronic Obstructive Pulmonary Disease Using Multiparametric Response Maps. Radiology. 2020 Apr;295(1):227-236. doi: 10.1148/radiol.2020191735. Epub 2020 Feb 25.
PubMed 32096708
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of 3He and 129Xe Magnetic Resonance Imaging in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02279329
- Acronym / sponsor ID
- ROB0018
- Conditions
- COPD, Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Grace ParragaUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- May 2009 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD and Bronchiectasis Patients | Other | Other: Hyperpolarized Helium MRIAll 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized Helium MRIHyperpolarized 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. | Other | COPD and Bronchiectasis Patients |
Primary outcome
Ventilation Defect Percent (VDP)
Time frame: 3 years
VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity
Apparent Diffusion Coefficients (ADC)
Time frame: 3 years
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.
3 secondary outcomes
Six Minute Walk Distance (6MWD)
Time frame: 3 years
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 3 years
Spirometry
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 11756734Salerno M, de Lange EE, Altes TA, Truwit JD, Brookeman JR, Mugler JP 3rd. Emphysema: hyperpolarized helium 3 diffusion MR imaging of the lungs compared with spirometric indexes--initial experience. Radiology. 2002 Jan;222(1):252-60. doi: 10.1148/radiol.2221001834.
- Background: PubMed 17968961Evans A, McCormack D, Ouriadov A, Etemad-Rezai R, Santyr G, Parraga G. Anatomical distribution of 3He apparent diffusion coefficients in severe chronic obstructive pulmonary disease. J Magn Reson Imaging. 2007 Dec;26(6):1537-47. doi: 10.1002/jmri.21205.
- Background: PubMed 18790402Mathew L, Evans A, Ouriadov A, Etemad-Rezai R, Fogel R, Santyr G, McCormack DG, Parraga G. Hyperpolarized 3He magnetic resonance imaging of chronic obstructive pulmonary disease: reproducibility at 3.0 tesla. Acad Radiol. 2008 Oct;15(10):1298-311. doi: 10.1016/j.acra.2008.04.019.
- Derived from this study: PubMed 42301257Tcherner S, Durom E, Peters J, Gater O, Parraga G. Airway Mucus Occlusions in Ex-Smokers with and Without COPD. COPD. 2026 Dec;23(1):2681969. doi: 10.1080/15412555.2026.2681969. Epub 2026 Jun 16.
- Derived from this study: PubMed 39221567Kooner HK, Wyszkiewicz PV, Matheson AM, McIntosh MJ, Abdelrazek M, Dhaliwal I, Nicholson JM, Kirby M, Svenningsen S, Parraga G. Chest CT Airway and Vascular Measurements in Females with COPD or Long-COVID. COPD. 2024 Dec;21(1):2394129. doi: 10.1080/15412555.2024.2394129. Epub 2024 Sep 2.
- Derived from this study: PubMed 37737132Sharma M, Wyszkiewicz PV, Matheson AM, McCormack DG, Parraga G. Chest MRI and CT Predictors of 10-Year All-Cause Mortality in COPD. COPD. 2023 Dec;20(1):307-320. doi: 10.1080/15412555.2023.2259224. Epub 2023 Sep 22.
- Derived from this study: PubMed 37395048Wyszkiewicz PV, Sharma M, Desaigoudar V, Cunningham IA, McCormack DG, Abdelrazek MA, Kirby M, Parraga G. Reduced Total Airway Count and Airway Wall Tapering after Three-Years in Ex-Smokers. COPD. 2023 Dec;20(1):186-196. doi: 10.1080/15412555.2023.2222831.
- Derived from this study: PubMed 33289613Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.
- Derived from this study: PubMed 32096708MacNeil JL, Capaldi DPI, Westcott AR, Eddy RL, Barker AL, McCormack DG, Kirby M, Parraga G. Pulmonary Imaging Phenotypes of Chronic Obstructive Pulmonary Disease Using Multiparametric Response Maps. Radiology. 2020 Apr;295(1):227-236. doi: 10.1148/radiol.2020191735. Epub 2020 Feb 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace E Parraga, PhD principal investigator
Robarts Research Institute, The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperpolarized Helium MRI in people with COPD and Bronchiectasis, run by Dr. Grace Parraga at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace E Parraga, PhD (519-931-5265, gparraga@robarts.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Defect Percent (VDP) (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02279329, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.