Idiopathic Pulmonary FibrosisPhase 2NCT05241275
Xenon MRI and Progressive ILD
A Phase 2 study testing Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment in people with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Duke University at 1 site in United States.
Trial summary
The XENON ILD study is a single arm, un-blinded study at Duke University enrolling patients with non-idiopathic pulmonary fibrosis (IPF) progressive fibrosis (PF) interstitial lung disease (ILD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
- What is being tested?
- Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 31 Aug 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include all patients who are over 18 years of age with a physician-diagnosed ILD of one of the below subtypes based on multidisciplinary consensus
- Chronic hypersensitivity pneumonitis
- Autoimmune interstitial lung disease (including rheumatoid arthritis-ILD, mixed connective tissue disorder related ILD, myositis related ILD, scleroderma related ILD, and idiopathic pneumonia with autoimmune features)
- Idiopathic NSIP
- Unclassifiable idiopathic interstitial pneumonia
- Fibrotic lung disease affecting more than 10% of lung volume on high-resolution CT, per Duke radiology review
Show all 12Show fewer
- Evidence of any of the following criteria for progression of ILD within the 24 months before screening:
- Relative decline in FVC % predicted of at least 10%
- Relative decline in FVC % predicted ≥ 5% - < 10 combined with either increasing extent of fibrotic changes on HRCT or worsening of respiratory symptoms
- Worsening respiratory symptoms and increased extent of fibrosis on HRCT
- Willing and able to give informed consent and adhere to visit/protocol schedules
- Immunosuppressive medication, including azathioprine, cyclosporine, mycophenolate mofetil, rituximab, cyclophosphamide, or oral glucocorticoids are permitted at the discretion of the treating physician
Who cannot join
- Subject is less than 18 years of age
- Prior treatment with nintedanib or pirfenidone
- Subject is pregnant or lactating
- Prior investigational drug use within 28 days
- MRI is contraindicated based on responses to MRI screening questionnaire
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
Show all 12Show fewer
- Acute exacerbation within 30 days of MRI, defined by acute increases in oxygen requirement, bilateral alveolar filling opacities on imaging, and the need for antibiotics and/or systemic steroids
- Subject does not fit into 129Xe vest coil used for MRI
- Subject with ventricular cardiac arrhythmia in the past 30 days.
- Subject has history of cardiac arrest within the last year
- Subject deemed unlikely to be able to comply with instructions during imaging
- Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XENON ILD: 129Xe MRI to Evaluate aNtifibrotic respOnse and progressioN in ILD
The XENON ILD study is a single arm, un-blinded study at Duke University enrolling patients with non-idiopathic pulmonary fibrosis (IPF) progressive fibrosis (PF) interstitial lung disease (ILD). Patients who meet criteria for ILD-progression (defined below in inclusion/exclusion criteria) will be consented prior to the initiation of anti-fibrotic therapy. Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyperpolarized 129Xe. The subjects will have this initial study prior to initiation of anti-fibrotic therapies and repeat MRI studies at 3, 6 and 12 months following the initiation of therapy. If subjects do not decide to initiate anti-fibrotic therapy per discussion with their physician, then the 3, 6 and 12 months repeat studies will initiate based on time after enrollment.
Read the detailed description
The XENON ILD study is a single arm, un-blinded study at Duke University enrolling patients with non-IPF PF-ILD. Patients who meet criteria for ILD-progression (defined below in inclusion/exclusion criteria) will be consented prior to the initiation of anti-fibrotic therapy. Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyperpolarized 129Xe. The subjects will have this initial study prior to initiation of anti-fibrotic therapies and repeat MRI studies at 3, 6 and 12 months following the initiation of therapy. If subjects do not decide to initiate anti-fibrotic therapy per discussion with their physician, then the 3, 6 and 12 months repeat studies will initiate based on time after enrollment. We plan to consent 75 subjects with PF-ILD who are candidates for anti-fibrotic therapy to slow ILD progression. We will ensure that the study will include at least 38 subjects who start anti-fibrotic therapy after baseline first MRI scan and continue the therapy until his/her 3 month repeat MRI scan. This will be obtained by a pre-specified increase in the number of subjects until the 38 subject criteria is completed. Subject will not be excluded from the study due to stopping anti-fibrotic therapy for any reason during the study.
Additional studies including pulmonary function studies, plasma and serum for biomarkers, whole blood for DNA (baseline visit only), whole blood for RNA, exhaled breath for biomarkers, 6 minute walk distance and a HRCT (only at the screening visit, 6 month visit, and 12 month visit) will be performed to determine how 129Xe MRI performs relative to standard of care evaluations for PF-ILD patients. Finally, following the study visits the research team will prospectively follow the patients' clinical course through periodic reviews of the medical record.
- Being tested
- Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment
- Keywords
- Magnetic Resonance Imaging
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis TreatmentDrug
Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Progressive Pulmonary Fibrosis | Experimental | Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis patients receiving approved treatments. Receives: Drug: Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 129Xe MRI barrier uptake 3 months after anti-fibrotic initiation
The outcome will assess changes in 129Xe MRI barrier uptake 3 months after nintedanib initiation.
Measured: Baseline, 3 months
Secondary outcomes (8)
Change in 129Xe MRI barrier uptake 6 months after anti-fibrotic initiation
The outcome will assess changes in 129Xe MRI barrier uptake 6 months after nintedanib initiation.
Measured: Baseline and 6 months
Change in 129Xe MRI RBC to barrier ratio 3 months after anti-fibrotic initiation
RBC to barrier ratio is a ratio of the RBC transfer and barrier values and is reported as a single value
Measured: Baseline and 3 months
Change in 129Xe MRI RBC to barrier ratio 6 months after anti-fibrotic initiation
RBC to barrier ratio is a ratio of the RBC transfer and barrier values and is reported as a single value
Measured: Baseline and 6 months
Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with elevated barrier uptake at baseline greater than 2 standard deviations of a healthy reference cohort
Time to disease progression will be recorded in months
Measured: Up to 12 months
Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with decreased RBC transfer at baseline, lower than 2 standard deviations of a healthy reference cohort
Time to disease progression will be recorded in months
Measured: Up to 12 months
Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with a reduced RBC to barrier ratio, greater than 2 standard deviations of a healthy reference cohort
RBC to barrier ratio is a ratio of the RBC transfer and barrier values and is reported as a single value. Time to disease progression will be recorded in months
Measured: Up to 12 months
Time to acute exacerbation or respiratory hospitalization in individuals with elevated barrier uptake at baseline greater than 2 standard deviations of a healthy reference cohort
Time to acute exacerbation or respiratory hospitalization will be an aggregate value and will be recorded in months
Measured: Up to 12 months
Time to acute exacerbation or respiratory hospitalization in individuals with decreased RBC transfer at baseline, lower than 2 standard deviations of a healthy reference cohort
Time to acute exacerbation or respiratory hospitalization will be an aggregate value and will be recorded in months
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start19 Jul 2022
- Primary completion3 Nov 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Bastiaan Driehuys, Duke University
- Investigators
- Robert M Tighe, MD, Principal investigator, Duke University Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241275
- Sponsor's protocol ID
- Pro00109322
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XENON ILD: 129Xe MRI to Evaluate aNtifibrotic respOnse and progressioN in ILD
- ClinicalTrials.gov ID
- NCT05241275
- Acronym / sponsor ID
- Pro00109322
- Keywords
- Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 15 Feb 2022 (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 XENON ILD study is a single arm, un-blinded study at Duke University enrolling patients with non-idiopathic pulmonary fibrosis (IPF) progressive fibrosis (PF) interstitial lung disease (ILD). Patients who meet criteria for ILD-progression (defined below in inclusion/exclusion criteria) will be consented prior to the initiation of anti-fibrotic therapy. Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyperpolarized 129Xe. The subjects will have this initial study prior to initiation of anti-fibrotic therapies and repeat MRI studies at 3, 6 and 12 months following the initiation of therapy. If subjects do not decide to initiate anti-fibrotic therapy per discussion with their physician, then the 3, 6 and 12 months repeat studies will initiate based on time after enrollment.
Detailed description
The XENON ILD study is a single arm, un-blinded study at Duke University enrolling patients with non-IPF PF-ILD. Patients who meet criteria for ILD-progression (defined below in inclusion/exclusion criteria) will be consented prior to the initiation of anti-fibrotic therapy. Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyperpolarized 129Xe. The subjects will have this initial study prior to initiation of anti-fibrotic therapies and repeat MRI studies at 3, 6 and 12 months following the initiation of therapy. If subjects do not decide to initiate anti-fibrotic therapy per discussion with their physician, then the 3, 6 and 12 months repeat studies will initiate based on time after enrollment. We plan to consent 75 subjects with PF-ILD who are candidates for anti-fibrotic therapy to slow ILD progression. We will ensure that the study will include at least 38 subjects who start anti-fibrotic therapy after baseline first MRI scan and continue the therapy until his/her 3 month repeat MRI scan. This will be obtained by a pre-specified increase in the number of subjects until the 38 subject criteria is completed. Subject will not be excluded from the study due to stopping anti-fibrotic therapy for any reason during the study.
Additional studies including pulmonary function studies, plasma and serum for biomarkers, whole blood for DNA (baseline visit only), whole blood for RNA, exhaled breath for biomarkers, 6 minute walk distance and a HRCT (only at the screening visit, 6 month visit, and 12 month visit) will be performed to determine how 129Xe MRI performs relative to standard of care evaluations for PF-ILD patients. Finally, following the study visits the research team will prospectively follow the patients' clinical course through periodic reviews of the medical record.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progressive Pulmonary Fibrosis | Experimental | Drug: Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis TreatmentWhether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis patients receiving approved treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- We will include all patients who are over 18 years of age with a physician-diagnosed ILD of one of the below subtypes based on multidisciplinary consensus
- Fibrotic lung disease affecting more than 10% of lung volume on high-resolution CT, per Duke radiology review
- Evidence of any of the following criteria for progression of ILD within the 24 months before screening:
- Willing and able to give informed consent and adhere to visit/protocol schedules
- Immunosuppressive medication, including azathioprine, cyclosporine, mycophenolate mofetil, rituximab, cyclophosphamide, or oral glucocorticoids are permitted at the discretion of the treating physician
Key exclusion criteria (12 listed)
- Subject is less than 18 years of age
- Prior treatment with nintedanib or pirfenidone
- Subject is pregnant or lactating
- Prior investigational drug use within 28 days
- MRI is contraindicated based on responses to MRI screening questionnaire
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 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis TreatmentWhether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis | Drug | Progressive Pulmonary Fibrosis |
Primary outcome
Change in 129Xe MRI barrier uptake 3 months after anti-fibrotic initiation
Time frame: Baseline, 3 months
The outcome will assess changes in 129Xe MRI barrier uptake 3 months after nintedanib initiation.
8 secondary outcomes
Change in 129Xe MRI barrier uptake 6 months after anti-fibrotic initiation
Time frame: Baseline and 6 months
Change in 129Xe MRI RBC to barrier ratio 3 months after anti-fibrotic initiation
Time frame: Baseline and 3 months
Change in 129Xe MRI RBC to barrier ratio 6 months after anti-fibrotic initiation
Time frame: Baseline and 6 months
Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with elevated barrier uptake at baseline greater than 2 standard deviations of a healthy reference cohort
Time frame: Up to 12 months
Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with decreased RBC transfer at baseline, lower than 2 standard deviations of a healthy reference cohort
Time frame: Up to 12 months
Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with a reduced RBC to barrier ratio, greater than 2 standard deviations of a healthy reference cohort
Time frame: Up to 12 months
Time to acute exacerbation or respiratory hospitalization in individuals with elevated barrier uptake at baseline greater than 2 standard deviations of a healthy reference cohort
Time frame: Up to 12 months
Time to acute exacerbation or respiratory hospitalization in individuals with decreased RBC transfer at baseline, lower than 2 standard deviations of a healthy reference cohort
Time frame: Up to 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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Robert M Tighe, MD principal investigator
Duke University Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment in people with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Duke University at 1 site in United States.
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 12 inclusion and 12 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 11 Jun 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in 129Xe MRI barrier uptake 3 months after anti-fibrotic initiation (time frame: Baseline, 3 months). 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 11 Jun 2026.