Interstitial Lung DiseasesPhase 2NCT04855305

Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

A Phase 2 study testing Hyperpolarized 129Xe in people with Interstitial Lung Diseases, run by Bastiaan Driehuys at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this multi-centered, NIH-sponsored study is to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Interstitial Lung Diseases
What is being tested?: Hyperpolarized 129Xe
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 12 Nov 2021to 11 Jun 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Outpatients of either gender, age greater than or equal to 18 years
Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
Subject has no diagnosed pulmonary conditions
Subject has not smoked in the previous 5 years
Smoking history, if any, is less than or equal to 5 pack-years

Show all 36Show fewer

No history of using other inhaled products more than 1 time per week for > 1 year
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:
Subject is less than 18 years old
MRI is contraindicated based on responses to MRI screening questionnaire
Subject is pregnant or lactating
Resting oxygen saturation on room air <90%
Respiratory illness of a bacterial or viral etiology within 30 days of MRI
Subject has history of any known ventricular cardiac arrhythmia
Subject has history of cardiac arrest within the last year
Subject does not fit into Xe vest coil used for MRI 129
Subject cannot hold his/her breath for 15 seconds
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
Inclusion/Exclusion Criteria for Subjects with Interstitial Lung Disease
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the trial:
Outpatients of either gender, age greater than or equal to 18 years
Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
Clinical diagnosis of Interstitial Lung Disease made by a board certified pulmonologist using established criteria. We will not exclude individuals based on ILD type or severity of disease with the exception of the below criteria
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:
Subject is less than 18 years old
MRI is contraindicated based on responses to MRI screening questionnaire
Subject is pregnant or lactating
Resting oxygen saturation <90% on supplemental oxygen
Respiratory illness of a bacterial or viral etiology within 30 days of MRI
Subject has history of any known ventricular cardiac arrhythmia.
Subject has history of cardiac arrest within the last year
Subject does not fit into Xe vest coil used for MRI 129
Subject cannot hold his/her breath for 15 seconds
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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Conditions: Interstitial Lung Diseases
Being tested: Hyperpolarized 129Xe
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperpolarized 129XeDrug
Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.

Study groups in NCT04855305
Study group	Role	What they receive
Patients with Interstitial Lung Disease	Active comparator	Not described Receives: Drug: Hyperpolarized 129Xe
Healthy Volunteers	Active comparator	Not described Receives: Drug: Hyperpolarized 129Xe

What is being measured

The primary outcome is the main question the study is designed to answer.

Thoracic Cavity Volume Measured in Liters
Measured: 1 day (immediately after administration of hyperpolarized 129 Xenon)
RBC/Barrier Signal Ratio (Unitless).
The RBC/Barrier Signal Ratio is a key quantitative metric in hyperpolarized Xe MRI that measures lung function by comparing the xenon signal in red blood cells (RBCs) to the signal in the pulmonary interstitial membrane (blood-gas barrier). It directly reflects how effectively xenon transfers across the membrane into the blood, with lower ratios indicating impairment in conditions like pulmonary fibrosis. For healthy individuals, this ratio is typically around a median (1Q-3Q) of 0.51 (0.45 - 0.57), while in subjects with pulmonary fibrosis, it can be significantly lower (e.g., 0.23 (0.21-0.24)).
Measured: 1 day (immediately after administration of hyperpolarized 129 Xenon)
Coefficient of Repeatability of RBC/Barrier Signal Ratio (Unitless).
A measure of how much maximum change in the RBC:Barrier is expected due to experimental variability. The coefficient of repeatability is calculated as 1.96 times the standard deviation observed in the RBC/barrier signal ratio.
Measured: 1 day (immediately after administration of hyperpolarized 129 Xenon)
Echo Time to Separate RBC and Barrier Signals by 90 Degrees (ms).
Measured: 1 day (immediately after administration of hyperpolarized 129 Xenon)
Population-wide RBC/Barrier Signal Ratio (Unitless).
The RBC/Barrier Signal Ratio is a key quantitative metric in hyperpolarized Xe MRI that measures lung function by comparing the xenon signal in red blood cells (RBCs) to the signal in the pulmonary interstitial membrane (blood-gas barrier). It directly reflects how effectively xenon transfers across the membrane into the blood, with lower ratios indicating impairment in conditions like pulmonary fibrosis. For healthy individuals, this ratio is typically around a median (1Q-3Q) of 0.51 (0.45 - 0.57), while in subjects with pulmonary fibrosis, it can be significantly lower (e.g., 0.23 (0.21-0.24)).
Measured: 1 day (immediately after administration of hyperpolarized 129 Xenon)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 202111 Jun 2025

First posted22 Apr 2021
Study start12 Nov 2021
Primary completion11 Jun 2025
Study completion11 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Interstitial Lung DiseasesStudies 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 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04855305
Sponsor's protocol ID: Pro00107570
Other IDs: R01HL126771
Status last verified: Jul 2026
First submitted: 19 Apr 2021
Last updated: 5 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Interstitial Lung Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
ClinicalTrials.gov ID: NCT04855305
Acronym / sponsor ID: Pro00107570
Conditions: Interstitial Lung Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Bastiaan DriehuysUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital Medical Center, Cincinnati, University of Cincinnati, University of Iowa
Study start: 12 Nov 2021 (actual)
Primary completion: 11 Jun 2025 (actual)
Study completion: 11 Jun 2025 (actual)
First posted: 22 Apr 2021 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patients with Interstitial Lung Disease	Active comparator	Drug: Hyperpolarized 129Xe
Healthy Volunteers	Active comparator	Drug: Hyperpolarized 129Xe

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (36 listed)

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Outpatients of either gender, age greater than or equal to 18 years
Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
Subject has no diagnosed pulmonary conditions
Subject has not smoked in the previous 5 years

Key exclusion criteria (0 listed)

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 129XeHyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.	Drug	Healthy Volunteers, Patients with Interstitial Lung Disease

Primary outcome

Thoracic Cavity Volume Measured in Liters
Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
RBC/Barrier Signal Ratio (Unitless).
Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
The RBC/Barrier Signal Ratio is a key quantitative metric in hyperpolarized Xe MRI that measures lung function by comparing the xenon signal in red blood cells (RBCs) to the signal in the pulmonary interstitial membrane (blood-gas barrier). It directly reflects how effectively xenon transfers across the membrane into the blood, with lower ratios indicating impairment in conditions like pulmonary fibrosis. For healthy individuals, this ratio is typically around a median (1Q-3Q) of 0.51 (0.45 - 0.57), while in subjects with pulmonary fibrosis, it can be significantly lower (e.g., 0.23 (0.21-0.24)).
Coefficient of Repeatability of RBC/Barrier Signal Ratio (Unitless).
Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
A measure of how much maximum change in the RBC:Barrier is expected due to experimental variability. The coefficient of repeatability is calculated as 1.96 times the standard deviation observed in the RBC/barrier signal ratio.
Echo Time to Separate RBC and Barrier Signals by 90 Degrees (ms).
Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
Population-wide RBC/Barrier Signal Ratio (Unitless).
Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
The RBC/Barrier Signal Ratio is a key quantitative metric in hyperpolarized Xe MRI that measures lung function by comparing the xenon signal in red blood cells (RBCs) to the signal in the pulmonary interstitial membrane (blood-gas barrier). It directly reflects how effectively xenon transfers across the membrane into the blood, with lower ratios indicating impairment in conditions like pulmonary fibrosis. For healthy individuals, this ratio is typically around a median (1Q-3Q) of 0.51 (0.45 - 0.57), while in subjects with pulmonary fibrosis, it can be significantly lower (e.g., 0.23 (0.21-0.24)).

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Interstitial Lung Disease	4	4
Healthy Volunteers	43	42

Primary outcome: Thoracic Cavity Volume Measured in Liters

Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon). Mean (Standard Deviation). Unit: Liters (L)

Measure	Patients With Interstitial Lung Disease n = 4	Healthy Volunteers n = 41
Value	2.8 (0.664)	3.43 (0.639)

Patients With Interstitial Lung Disease vs Healthy Volunteers: p = 0.1518, Welch Two Sample T-Test

Primary outcome: RBC/Barrier Signal Ratio (Unitless).

Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon). Mean (Standard Deviation). Unit: unitless RBC:Barrier signal ratio

Measure	Patients With Interstitial Lung Disease n = 4	Healthy Volunteers n = 41
Value	0.326 (0.0681)	0.474 (0.121)

Patients With Interstitial Lung Disease vs Healthy Volunteers: p = 0.01209, Welch Two Sample T-test

Primary outcome: Coefficient of Repeatability of RBC/Barrier Signal Ratio (Unitless).

Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon). Mean (Standard Deviation). Unit: coefficient of repeatability

Measure	Healthy Volunteers n = 23
Value	0.474 (0.12)

Healthy Volunteers: Bland- Altman: 0.0148 (95% CI -0.171 to 0.200)

Population analysed: The repeatability study was only conducted on the Healthy Volunteer arm. Healthy Volunteers that only completed one scan were not included as repeatability is unable to be determined.

Primary outcome: Echo Time to Separate RBC and Barrier Signals by 90 Degrees (ms).

Time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon). Mean (Standard Deviation). Unit: ms

Measure	Patients With Interstitial Lung Disease n = 4	Healthy Volunteers n = 41
Value	482 (23.6)	466 (16.6)

Patients With Interstitial Lung Disease vs Healthy Volunteers: p = 0.2548, Welch Two Sample T-Test

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Interstitial Lung Disease	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Healthy Volunteers	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.

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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.

Joseph Mammarappallil, MD principal investigator

Duke University

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 129Xe in people with Interstitial Lung Diseases, run by Bastiaan Driehuys 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 36 inclusion and 0 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 5 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 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?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Thoracic Cavity Volume Measured in Liters (time frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)). The study lists 5 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 NCT04855305.

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 5 Aug 2026.