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

July 10, 2026 updated by: Bastiaan Driehuys
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion/Exclusion Criteria for Healthy Volunteers

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Outpatients of either gender, age greater than or equal to 18 years
  2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
  3. Subject has no diagnosed pulmonary conditions
  4. Subject has not smoked in the previous 5 years
  5. Smoking history, if any, is less than or equal to 5 pack-years
  6. 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:

  1. Subject is less than 18 years old
  2. MRI is contraindicated based on responses to MRI screening questionnaire
  3. Subject is pregnant or lactating
  4. Resting oxygen saturation on room air <90%
  5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  6. Subject has history of any known ventricular cardiac arrhythmia
  7. Subject has history of cardiac arrest within the last year
  8. Subject does not fit into Xe vest coil used for MRI 129
  9. Subject cannot hold his/her breath for 15 seconds
  10. Subject deemed unlikely to be able to comply with instructions during imaging
  11. 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:

  1. Outpatients of either gender, age greater than or equal to 18 years
  2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
  3. 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:

  1. Subject is less than 18 years old
  2. MRI is contraindicated based on responses to MRI screening questionnaire
  3. Subject is pregnant or lactating
  4. Resting oxygen saturation <90% on supplemental oxygen
  5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  6. Subject has history of any known ventricular cardiac arrhythmia.
  7. Subject has history of cardiac arrest within the last year
  8. Subject does not fit into Xe vest coil used for MRI 129
  9. Subject cannot hold his/her breath for 15 seconds
  10. Subject deemed unlikely to be able to comply with instructions during imaging
  11. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Patients with Interstitial Lung Disease
Drug: Hyperpolarized 129Xe
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.
Active Comparator: Healthy Volunteers
Drug: Hyperpolarized 129Xe
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thoracic Cavity Volume Measured in Liters
Time Frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
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)).
1 day (immediately after administration of hyperpolarized 129 Xenon)
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.
1 day (immediately after administration of hyperpolarized 129 Xenon)
Echo Time to Separate RBC and Barrier Signals by 90 Degrees (ms).
Time Frame: 1 day (immediately after administration of hyperpolarized 129 Xenon)
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)).
1 day (immediately after administration of hyperpolarized 129 Xenon)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bastiaan Driehuys

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
University of Iowa
Children's Hospital Medical Center, Cincinnati
University of Cincinnati

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Mammarappallil, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00107570
  • R01HL126771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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. In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.

IPD Sharing Access Criteria

We are committed to making de-identified datasets and image analysis available to to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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