Lung DiseaseNCT02723474
A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease
A study testing MRI at baseline and over time in people with Lung Disease, run by Western University, Canada at 1 site in Canada.
Trial summary
Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight) hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Disease
- What is being tested?
- MRI at baseline and over time
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects male and female aged 18-75 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, lymphangioleiomyomatosis (LAM) and Bronchiolitis obliterans organizing pneumonia (BOOP)
- 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 able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume in one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
- FEV1 >25% predicted
- Forced Vital Capacity (FVC) > 25% predicted and >0.5Liters
Who cannot join
- Subject with a contraindication to Magnetic Resonance Imaging (i.e. ferrous implants, cardiac pacemakers). This will be determined through a screening form.
- Subject has a daytime room air oxygen saturation <90% while lying supine.
- Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
- Subject previously injured by a metallic object that was not removed.
- 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
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7
About this study
Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight) hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.
Read the detailed description
Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo:
- brief medical history and vital signs,
- full pulmonary function tests,
- proton MRI,
- spin-density and/or diffusion weighted Helium-3 MRI.
Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.
- Conditions
- Lung Disease
- Being tested
- MRI at baseline and over time
- Keywords
- Magnetic Resonance Imaging, Pulmonary Function
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI at baseline and over timeDevice
Hyperpolarized noble gas MRI has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI, Helium-3 and Xenon-129 gas is used as a contrast agent to directly visualize ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
| Study group | Role | What they receive |
|---|---|---|
| MRI at baseline and over time | Other | Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Helium and or Xenon MRI at each visit. Receives: Device: MRI at baseline and over time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function as measured using inhaled gas MRI ventilation defect percent (VDP)
Lung function will be measured using inhaled gas MRI ventilation defect percent
Measured: 5 years
Secondary outcomes (1)
Lung microstructure as measured using inhaled gas MRI Apparent Diffusion Coefficients (ADC)
Lung microstructure as measured using inhaled gas MRI ADC
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startNov 2007
- Primary completionJan 2025
- Study completionJan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Grace Parraga, Western University, Canada
- Investigators
- Grace E Parraga, PhD, Principal investigator, Robarts Research Institute, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723474
- Sponsor's protocol ID
- ROB0010
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2015
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Westcott A, Capaldi DPI, McCormack DG, Ward AD, Fenster A, Parraga G. Chronic Obstructive Pulmonary Disease: Thoracic CT Texture Analysis and Machine Learning to Predict Pulmonary Ventilation. Radiology. 2019 Dec;293(3):676-684. doi: 10.1148/radiol.2019190450. Epub 2019 Oct 22.
PubMed 31638491Kirby M, Eddy RL, Pike D, Svenningsen S, Coxson HO, Sin DD, McCormack DG, Parraga G; Canadian Respiratory Research Network. MRI ventilation abnormalities predict quality-of-life and lung function changes in mild-to-moderate COPD: longitudinal TINCan study. Thorax. 2017 May;72(5):475-477. doi: 10.1136/thoraxjnl-2016-209770. Epub 2017 Mar 3.
PubMed 28258250
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT02723474
- Acronym / sponsor ID
- ROB0010
- Conditions
- Lung Disease
- Keywords
- Magnetic Resonance Imaging, Pulmonary Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Jan 2025 (actual)
- Study completion
- Jan 2025 (actual)
- First posted
- 30 Mar 2016 (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.
Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight) hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.
Detailed description
Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo:
- brief medical history and vital signs,
- full pulmonary function tests,
- proton MRI,
- spin-density and/or diffusion weighted Helium-3 MRI.
Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI at baseline and over time | Other | Device: MRI at baseline and over timePatients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Helium and or Xenon MRI at each visit. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects male and female aged 18-75 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, lymphangioleiomyomatosis (LAM) and Bronchiolitis obliterans organizing pneumonia (BOOP)
- 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 able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume in one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
Key exclusion criteria (6 listed)
- Subject with a contraindication to Magnetic Resonance Imaging (i.e. ferrous implants, cardiac pacemakers). This will be determined through a screening form.
- Subject has a daytime room air oxygen saturation <90% while lying supine.
- Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
- Subject previously injured by a metallic object that was not removed.
- 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 |
|---|---|---|
| MRI at baseline and over timeHyperpolarized noble gas MRI has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI, Helium-3 and Xenon-129 gas is used as a contrast agent to directly visualize ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping. | Device | MRI at baseline and over time |
Primary outcome
Lung function as measured using inhaled gas MRI ventilation defect percent (VDP)
Time frame: 5 years
Lung function will be measured using inhaled gas MRI ventilation defect percent
1 secondary outcome
Lung microstructure as measured using inhaled gas MRI Apparent Diffusion Coefficients (ADC)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 31638491Westcott A, Capaldi DPI, McCormack DG, Ward AD, Fenster A, Parraga G. Chronic Obstructive Pulmonary Disease: Thoracic CT Texture Analysis and Machine Learning to Predict Pulmonary Ventilation. Radiology. 2019 Dec;293(3):676-684. doi: 10.1148/radiol.2019190450. Epub 2019 Oct 22.
- Derived from this study: PubMed 28258250Kirby M, Eddy RL, Pike D, Svenningsen S, Coxson HO, Sin DD, McCormack DG, Parraga G; Canadian Respiratory Research Network. MRI ventilation abnormalities predict quality-of-life and lung function changes in mild-to-moderate COPD: longitudinal TINCan study. Thorax. 2017 May;72(5):475-477. doi: 10.1136/thoraxjnl-2016-209770. Epub 2017 Mar 3.
Related trials for Lung Disease
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingObservational study
68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis
Medullary Thyroid Carcinoma, Small Cell Lung Cancer ( SCLC )
RecruitingPhase 3
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
Severe Asthma
RecruitingPhase 2/3
The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
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 MRI at baseline and over time in people with Lung Disease, run by Western University, Canada 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 7 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: finished, as of the sponsor's last update on 11 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function as measured using inhaled gas MRI ventilation defect percent (VDP) (time frame: 5 years). 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 NCT02723474, which also lists 2 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 11 Aug 2025.