Progressive Fibrosing Interstitial Lung DiseaseNCT05914506
Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease
An observational study of Progressive Fibrosing Interstitial Lung Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Progressive Fibrosing Interstitial Lung Disease
- What is being tested?
- Hyperpolarized xenon-129 MRI
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Oct 2023to 1 May 2028
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have recently recieved a diagnosis of progressive fibrosing interstial lung disease and are expected to recieve antifibrotic therapy
Who may be able to join
- Informed signed consent
- Age 18-90
- Pre-menopausal women must be confirmed non-pregnant by an onsite test.
- Patients diagnosed with IPF or fibrotic ILD who fulfills PPF criteria, and are prescribed antifibrotic treatment.
- Cognitively able to understand and participate in the study
Who cannot join
- Contraindications for MRI:
- Pacemaker, neurostimulator or cochlear implant
- Metal foreign bodies such as fragments and irremovable piercings
- Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
- Intrathoracic clips or coils
- Cardiac pacemakers
Show all 16Show fewer
- Claustrophobia
- Largest circumference including arms > 160 cm
- Contraindications to gadolinium contrast
- eGFR < 30 mL/min/1.73m2
- Previous adverse reactions to gadolinium
- Overlapping emphysemic disease where the emphysema-component outweighs the fibrosis
- Unable to perform breath-hold of minimum 20 seconds.
- Allergy to Xenon
- Breast feeding
- Evidence of ongoing respiratory infections at time of MR examinations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Clinical Medicine, MR Research Centre
Aarhus, 8200
About this study
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeutic responses to anti-fibrotic drugs.
Read the detailed description
Fibrosing interstitial lung diseases (F-ILD) represent a heterogeneous disease category involving several disease entities with different clinical, radiological, and histological characteristics. The common denominator for F-ILD patients is similarities regarding development of scarring of the lungs. Idiopathic pulmonary fibrosis (IPF) is the prototype, and all patients will eventually suffer from irreversible progression. In other type of F-ILD, a proportion of patients will also develop symptom worsening, treatment resistance towards immunomodulatory therapy, a decline in lung physiological parameters, worsening of radiologic findings and irreversible self-sustaining progression of pulmonary fibrosis i.e., a phenotype of progressive pulmonary fibrosis (PPF), defined by worsening of symptoms, lung physiology and radiology within 12 months Chest High Resolution Computed Tomography (HRCT) is considered the golden standard to diagnose and quantify the type and extent of pulmonary fibrosis. Extent of fibrosis and specific features like traction bronchiectasis and honeycombing seem in some disease to be associated with a worse outcome. However, findings do not always correspond to disease severity or disease course, and at later stages, HRCT is limited in proving the progression of the disease. Identifying progression is currently based on a decrease in forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), worsening of symptoms or progression of radiologic features (Table 1). Identification of radiologic biomarkers for progression will allow to better support treatment decisions and inform patients. Patients with F-ILD often suffer from a high burden of comorbidities, including ischemic heart disease, congestive heart failure, and pulmonary hypertension. It is currently unknown if these is solely associated to common risk factors like smoking and age, or could be due to fibrosis developing in the myocardium. Furthermore, it is not well described if the development of a restrictive lung physiology plays a role and affects cardiac physiology.
This study proposes that MR (magnetic resonance) Imaging with hyperpolarized 129Xenon will be able to detect subtle, regional dysfunction of the gas exchange of the lungs in patients with F-ILDs at a higher level of sensitivity than currently applied techniques. Utilizing the improved sensitivity of the hyperpolarized xenon MRI the study aims to improve the diagnostic distinction between the different subtypes of F-ILDs and additionally point-out MR biomarkers to be assess F-ILD severity, progression, and potential treatment response. Simultaneously with the hyperpolarized 129Xe scans, imaging of myocardial strain and ejection fraction is performed. In addition, a Gadolinium Based Contrast Agent (GBCA) is administered to evaluate the degree of myocardial fibrous tissue and lung perfusion. Thus, the impact of thoracic restrictive physiology on the heart can be detected and quantified.
- Being tested
- Hyperpolarized xenon-129 MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized xenon-129 MRIDiagnostic test
Participants will be asked to inhale the xenon-129 contrast agent according to procedure for gas administration. The success criterion of the drug is a obtained Xe MRI lung image with reasonable signal level
What is being measured
The primary outcome is the main question the study is designed to answer.
Xenon gas transfer
Gas transfer across the lung barrier measured using dissolved phase Xe-129 gas MRI spectroscopy.
From this measure we expect to see an increase in the tissue signal and a decrease in the blood signal as a measure of IPF disease activity.
We expect the change in ratio to be more than 10% when comparing baseline results to follow-up at subject level.
Results will be compared to clinical outcome measures of progression (outcome 2)
Measured: 12 months
Individual clinical progression in the study period (progressors and non-progressors)
Current accepted criteria for progression of fibrosing interstitial lung diseases (at least 2 of 3):
- Worsening of clinical symptoms (estimated by qualified physician. Additionally this will be quantified by patient related outcome measures, (K-BILD, SOBQ and L-PF)
- Decline in pulmonary function test parameters (decrease of FVC >= 5% and/or DLCO >= 10%)
- Radiological evidence of disease progression:
- Increased extent or severity of traction bronchiectasis and bronchiolectasis
- New ground-glass opacity with traction bronchiectasis
- New fine reticulation
- Increased extent or increased coarseness of reticular abnormality
- New or increased honeycombing
- Increased lobar volume loss.
Measured: 12 months
Secondary outcomes (5)
Pulmonary perfusion
Regionally decreased pulmonary perfusion in ml/g/min measured by gadolinium enhanced MRI
Measured: 12 months
Myocardial strain
Evidence of myocardial strain measured by relative myocardial deformation through the cardiac cycle in percentage with CINE MRI
Measured: 12 months
Fibrous tissue formation
Formation of fibrotic tissue measured with late-contrast enhancement and evaluated as MRI signal intensity changes before and after intravenous gadolinium injection.
Measured: 12 months
Xenon ventilation distribution
Ventilation defect is measured by xenon gas distribution in the lungs. Ventilation defect percentage is quantified by xenon MRI signal divided by whole lung volume.
Measured: 12 months
Xenon gas diffusion
The diffusion of xenon gas in the alveoli. Gas diffusion is measured with diffusion-weighted xenon MRI as gas-molecule speed (cm/s)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start5 Oct 2023
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Fibrosing Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Elisabeth Bendstrup, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914506
- Sponsor's protocol ID
- Xe-F-ILD-001
- Other IDs
- 2022-502512-36-00, U1111-1284-7436
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05914506
- Acronym / sponsor ID
- Xe-F-ILD-001
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 22 Jun 2023 (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.
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeutic responses to anti-fibrotic drugs.
Detailed description
Fibrosing interstitial lung diseases (F-ILD) represent a heterogeneous disease category involving several disease entities with different clinical, radiological, and histological characteristics. The common denominator for F-ILD patients is similarities regarding development of scarring of the lungs. Idiopathic pulmonary fibrosis (IPF) is the prototype, and all patients will eventually suffer from irreversible progression. In other type of F-ILD, a proportion of patients will also develop symptom worsening, treatment resistance towards immunomodulatory therapy, a decline in lung physiological parameters, worsening of radiologic findings and irreversible self-sustaining progression of pulmonary fibrosis i.e., a phenotype of progressive pulmonary fibrosis (PPF), defined by worsening of symptoms, lung physiology and radiology within 12 months Chest High Resolution Computed Tomography (HRCT) is considered the golden standard to diagnose and quantify the type and extent of pulmonary fibrosis. Extent of fibrosis and specific features like traction bronchiectasis and honeycombing seem in some disease to be associated with a worse outcome. However, findings do not always correspond to disease severity or disease course, and at later stages, HRCT is limited in proving the progression of the disease. Identifying progression is currently based on a decrease in forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), worsening of symptoms or progression of radiologic features (Table 1). Identification of radiologic biomarkers for progression will allow to better support treatment decisions and inform patients. Patients with F-ILD often suffer from a high burden of comorbidities, including ischemic heart disease, congestive heart failure, and pulmonary hypertension. It is currently unknown if these is solely associated to common risk factors like smoking and age, or could be due to fibrosis developing in the myocardium. Furthermore, it is not well described if the development of a restrictive lung physiology plays a role and affects cardiac physiology.
This study proposes that MR (magnetic resonance) Imaging with hyperpolarized 129Xenon will be able to detect subtle, regional dysfunction of the gas exchange of the lungs in patients with F-ILDs at a higher level of sensitivity than currently applied techniques. Utilizing the improved sensitivity of the hyperpolarized xenon MRI the study aims to improve the diagnostic distinction between the different subtypes of F-ILDs and additionally point-out MR biomarkers to be assess F-ILD severity, progression, and potential treatment response. Simultaneously with the hyperpolarized 129Xe scans, imaging of myocardial strain and ejection fraction is performed. In addition, a Gadolinium Based Contrast Agent (GBCA) is administered to evaluate the degree of myocardial fibrous tissue and lung perfusion. Thus, the impact of thoracic restrictive physiology on the heart can be detected and quantified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have recently recieved a diagnosis of progressive fibrosing interstial lung disease and are expected to recieve antifibrotic therapy
Key inclusion criteria (5 listed)
- Informed signed consent
- Age 18-90
- Pre-menopausal women must be confirmed non-pregnant by an onsite test.
- Patients diagnosed with IPF or fibrotic ILD who fulfills PPF criteria, and are prescribed antifibrotic treatment.
- Cognitively able to understand and participate in the study
Key exclusion criteria (16 listed)
- Contraindications for MRI:
- Contraindications to gadolinium contrast
- Overlapping emphysemic disease where the emphysema-component outweighs the fibrosis
- Unable to perform breath-hold of minimum 20 seconds.
- Allergy to Xenon
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 xenon-129 MRIParticipants will be asked to inhale the xenon-129 contrast agent according to procedure for gas administration. The success criterion of the drug is a obtained Xe MRI lung image with reasonable signal level | Diagnostic test | – |
Primary outcome
Xenon gas transfer
Time frame: 12 months
Gas transfer across the lung barrier measured using dissolved phase Xe-129 gas MRI spectroscopy. From this measure we expect to see an increase in the tissue signal and a decrease in the blood signal as a measure of IPF disease activity. We expect the change in ratio to be more than 10% when comparing baseline results to follow-up at subject level. Results will be compared to clinical outcome measures of progression (outcome 2)
Individual clinical progression in the study period (progressors and non-progressors)
Time frame: 12 months
Current accepted criteria for progression of fibrosing interstitial lung diseases (at least 2 of 3): 1. Worsening of clinical symptoms (estimated by qualified physician. Additionally this will be quantified by patient related outcome measures, (K-BILD, SOBQ and L-PF) 2. Decline in pulmonary function test parameters (decrease of FVC >= 5% and/or DLCO >= 10%) 3. Radiological evidence of disease progression: 1. Increased extent or severity of traction bronchiectasis and bronchiolectasis 2. New ground-glass opacity with traction bronchiectasis 3. New fine reticulation 4. Increased extent or increased coarseness of reticular abnormality 5. New or increased honeycombing 6. Increased lobar volume loss.
5 secondary outcomes
Pulmonary perfusion
Time frame: 12 months
Myocardial strain
Time frame: 12 months
Fibrous tissue formation
Time frame: 12 months
Xenon ventilation distribution
Time frame: 12 months
Xenon gas diffusion
Time frame: 12 months
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 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Progressive Fibrosing Interstitial Lung Disease
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A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
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Early Recognition of Progressive Lung Fibrosis in Systemic Rheumatic Diseases
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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.
Elisabeth Bendstrup, Professor principal investigator
Aarhus University Hospital
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 Progressive Fibrosing Interstitial Lung Disease, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 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 Denmark. 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?
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?
Xenon gas transfer (time frame: 12 months). 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?
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 9 Dec 2025.