Fibrotic Interstitial Lung DiseaseMASTER-ILDNCT07786090
Mechanistic 129 Xe MRI Study to Assess Therapeutic Response in Fibrotic Interstitial Lung Disease
An observational study of Fibrotic Interstitial Lung Disease, run by Dr. Grace Parraga at 1 site in Canada.
Trial summary
The goal of this observational study is to better understand how treatment affects the lungs of adults (ages 18-80) with fibrotic interstitial lung diseases. The main questions it aims to answer are: Can advanced imaging detect the effect of currently approved therapies on people with fibrotic interstitial lung… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibrotic Interstitial Lung Disease
- What is being tested?
- Hyperpolarized 129Xe MRI
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to Jan 2029
- How long will I take part?
- 50 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be adults 18-80 years of age with physician-diagnosed fibrotic interstitial lung disease consistent with 2022 ATS/ERS guidelines and are eligible for antifibrotic therapy. Participants will be referred from respirologists at LHSC London outpatient respirology clinics.
Who may be able to join
- Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
- Provision of written, informed consent prior to any study specific procedures.
- Males and females >/= 18 years of age
- Patient has a current diagnosis of fILD by a respirologist according to the 2022 ATS/ERS guidelines and is eligible for antifibrotic therapy.
- Women of childbearing potential must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit.
- Women of childbearing potential must agree to use a highly effective form of birth control from enrollment, throughout the study duration, with negative urine pregnancy test result at Visits 1, 2, and 3.
Who cannot join
- Patient 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)
- In the investigator's opinion, subject suffers from any physical, psychological or other conditions that might prevent performance of the MRI or CT, such as severe claustrophobia.
- Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
- Participant is unable to perform spirometry or plethysmography maneuvers.
- Participant is unable to perform MRI and CT breath-hold maneuvers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7
Grace Parraga, PhD, 519-931-5265, gparraga@uwo.ca
Andraena K Tilgner, BHSc., RRT, 519-661-2111 ext. 89853, atilgner@uwo.ca
About this study
The goal of this observational study is to better understand how treatment affects the lungs of adults (ages 18-80) with fibrotic interstitial lung diseases. The main questions it aims to answer are:
- Can advanced imaging detect the effect of currently approved therapies on people with fibrotic interstitial lung diseases?
- What is the relationship between the response to therapy and the imaging response to therapy?
Read the detailed description
This is a prospective, single site, observational study in adults aged 18-80 who have fibrotic interstitial lung disease (fILD), and are scheduled to start antifibrotic therapy as prescribed by their treating respirologist. Therapeutic treatment will be assigned in a non-randomized manner by the treating respirologist. There will be no control intervention or blinding.
Each participant will participate in three study visits over a one-year period; Visit 1 - before start of treatment Visit 2 - after 24 weeks of therapy Visit 3 - after 48 weeks of therapy
Each visit will include; a blood test - Complete Blood Count (CBC), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR); Pulmonary Function testing (PFT) that includes spirometry, plethysmography, diffusion capacity, oscillometry; urine pregnancy test (if indicated); St George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease (K-BILD) questionnaire; 129Xenon Magnetic Resonance Imaging (129Xe MRI); Low-dose chest Computed Tomography (CT) /High Resolution Computed Tomography (HRCT) scan; Six-Minute Walk Test (6MWT) with Borg rating of perceived exertion and dyspnea (BORG) questionnaires.
- Conditions
- Fibrotic Interstitial Lung Disease
- Being tested
- Hyperpolarized 129Xe MRI
- Keywords
- Hyperpolarized 129Xe MRI, MRI, Pulmonary Function Testing, fILD, Fibrotic Interstitial Lung Disease, Antifibrotic Therapy, Therapeutic Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129Xe MRIOther
Inhalation of hyperpolarized 129Xe gas followed by breath-hold MRI for ventilation imaging.
| Study group | Role | What they receive |
|---|---|---|
| Fibrotic Interstitial Lung Disease | Not described Receives: Other: Hyperpolarized 129Xe MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure 129Xe imaging ventilation defects qualitatively and quantitatively in participants diagnosed with fibrotic interstitial lung disease.
The extent and timing of clinical and imaging-based physiologic changes following treatment initiation for fibrotic interstitial lung disease will be assessed using conventional assessments and advanced pulmonary imaging (MRI and CT). Measurements will include 129Xe compartment-specific physiologic abnormalities and ventilation defect percent (VDP), Pulmonary Function Test (PFT) including Forced Vital Capacity (FVC), Total Lung Capacity (TLC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), Six-Minute Walk Test (6MWT), symptom scores from St George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease (KBILD) questionnaires, CT parenchyma/airway/vessel morphology.
Measured: 3 visits; Visit 1 at baseline, before treatment initiation. Visit 2 at 24 weeks post-treatment initiation. Visit 3 at 48 weeks post treatment initiation. Each visit will include MRI and CT imaging, Blood test, PFT, questionnaires and 6MWT.
Secondary outcomes (1)
Determine the relationships between clinical and imaging response to therapy and generate predictive models for their achievement at 1-year using baseline markers and their changes at 24 weeks.
Observe changes in 129Xe compartment-specific physiologic abnormalities, changes in ventilation defect percent (VDP), Changes in CT (for progression in fibrotic disease), PFT, 6MWT, SGRQ-I, KBILD.
Measured: From baseline to 1 year post-therapy initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrotic Interstitial Lung DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 50 Weeks
Sponsor and investigators
- Lead sponsor
- Dr. Grace Parraga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT07786090
- Sponsor's protocol ID
- ROB0064
- Acronym
- MASTER-ILD
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic 129 Xe MRI Study to Assess Therapeutic Response in Fibrotic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07786090
- Acronym / sponsor ID
- MASTER-ILD / ROB0064
- Conditions
- Fibrotic Interstitial Lung Disease
- Keywords
- Hyperpolarized 129Xe MRI, MRI, Pulmonary Function Testing, fILD, Fibrotic Interstitial Lung Disease, Antifibrotic Therapy, Therapeutic Response
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Dr. Grace ParragaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- 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.
The goal of this observational study is to better understand how treatment affects the lungs of adults (ages 18-80) with fibrotic interstitial lung diseases. The main questions it aims to answer are:
- Can advanced imaging detect the effect of currently approved therapies on people with fibrotic interstitial lung diseases?
- What is the relationship between the response to therapy and the imaging response to therapy?
Detailed description
This is a prospective, single site, observational study in adults aged 18-80 who have fibrotic interstitial lung disease (fILD), and are scheduled to start antifibrotic therapy as prescribed by their treating respirologist. Therapeutic treatment will be assigned in a non-randomized manner by the treating respirologist. There will be no control intervention or blinding.
Each participant will participate in three study visits over a one-year period; Visit 1 - before start of treatment Visit 2 - after 24 weeks of therapy Visit 3 - after 48 weeks of therapy
Each visit will include; a blood test - Complete Blood Count (CBC), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR); Pulmonary Function testing (PFT) that includes spirometry, plethysmography, diffusion capacity, oscillometry; urine pregnancy test (if indicated); St George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease (K-BILD) questionnaire; 129Xenon Magnetic Resonance Imaging (129Xe MRI); Low-dose chest Computed Tomography (CT) /High Resolution Computed Tomography (HRCT) scan; Six-Minute Walk Test (6MWT) with Borg rating of perceived exertion and dyspnea (BORG) questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibrotic Interstitial Lung Disease | – | Other: Hyperpolarized 129Xe MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adults 18-80 years of age with physician-diagnosed fibrotic interstitial lung disease consistent with 2022 ATS/ERS guidelines and are eligible for antifibrotic therapy. Participants will be referred from respirologists at LHSC London outpatient respirology clinics.
Key inclusion criteria (6 listed)
- Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature.
- Provision of written, informed consent prior to any study specific procedures.
- Males and females >/= 18 years of age
- Patient has a current diagnosis of fILD by a respirologist according to the 2022 ATS/ERS guidelines and is eligible for antifibrotic therapy.
- Women of childbearing potential must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit.
Key exclusion criteria (5 listed)
- Patient 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)
- In the investigator's opinion, subject suffers from any physical, psychological or other conditions that might prevent performance of the MRI or CT, such as severe claustrophobia.
- Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit.
- Participant is unable to perform spirometry or plethysmography maneuvers.
- Participant is unable to perform MRI and CT breath-hold maneuvers.
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 129Xe MRIInhalation of hyperpolarized 129Xe gas followed by breath-hold MRI for ventilation imaging. | Other | Fibrotic Interstitial Lung Disease |
Primary outcome
Measure 129Xe imaging ventilation defects qualitatively and quantitatively in participants diagnosed with fibrotic interstitial lung disease.
Time frame: 3 visits; Visit 1 at baseline, before treatment initiation. Visit 2 at 24 weeks post-treatment initiation. Visit 3 at 48 weeks post treatment initiation. Each visit will include MRI and CT imaging, Blood test, PFT, questionnaires and 6MWT.
The extent and timing of clinical and imaging-based physiologic changes following treatment initiation for fibrotic interstitial lung disease will be assessed using conventional assessments and advanced pulmonary imaging (MRI and CT). Measurements will include 129Xe compartment-specific physiologic abnormalities and ventilation defect percent (VDP), Pulmonary Function Test (PFT) including Forced Vital Capacity (FVC), Total Lung Capacity (TLC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), Six-Minute Walk Test (6MWT), symptom scores from St George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease (KBILD) questionnaires, CT parenchyma/airway/vessel morphology.
1 secondary outcome
Determine the relationships between clinical and imaging response to therapy and generate predictive models for their achievement at 1-year using baseline markers and their changes at 24 weeks.
Time frame: From baseline to 1 year post-therapy initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Fibrotic Interstitial Lung Disease
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation
Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Interstitial Lung Disease (ILD), Suspected Interstitial Lung Disease
Active, not recruiting
Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease
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.
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?
An observational study of Fibrotic Interstitial Lung Disease, 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measure 129Xe imaging ventilation defects qualitatively and quantitatively in participants diagnosed with fibrotic interstitial lung disease. (time frame: 3 visits; Visit 1 at baseline, before treatment initiation. Visit 2 at 24 weeks post-treatment initiation. Visit 3 at 48 weeks post treatment initiation. Each visit will include MRI and CT imaging, Blood test, PFT, questionnaires and 6MWT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.