Interstitial Lung DiseasePhase 2NCT01280994
Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
A Phase 2 study testing Hyperpolarized 129Xenon Gas in people with Interstitial Lung Disease, run by Bastiaan Driehuys at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the… 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 Disease
- What is being tested?
- Hyperpolarized 129Xenon Gas
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2030
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Subject has a diagnosis of pulmonary dysfunction made by a physician
- No acute worsening of pulmonary function in the past 30 days
Who cannot join
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI screening questionaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
- Subject has any form of known cardiac arrhythmia
Show all 9Show fewer
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Bastiaan Driehuys, Ph.D
Joseph Mammarappallil, MD, PhD
About this study
Official title: Hyperpolarized 129Xe MR Imaging of the Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Read the detailed description
Non-invasive imaging of pulmonary function is expected to provide critical insights that are needed to spur progress in characterizing and treating chronic pulmonary diseases. The current primary diagnostic measure is pulmonary function testing (PFT), which was introduced in the mid-19th century, yet remains the standard of care today. PFTs have the advantage of being non-invasive and widely available, but suffer from poor sensitivity and high variability. Thus, PFTs are ineffective in assessing therapeutic response or disease progression on reasonable time scales, given the frequent heterogeneity of disease and the lung's compensatory mechanisms.
It has long been appreciated that improving sensitivity requires assessing the lungs regionally. To this end, methods, such as computed tomography (CT), provide insights into lung structure, but lung function must be inferred. However, of greater concern is the high radiation dose associated with CT, which precludes frequent longitudinal follow-up imaging. Alternatively, regional imaging of both ventilation and perfusion is possible using nuclear medicine techniques such as planar scintigraphy, single photon computed tomography (SPECT), or positron emission tomography (PET). However, as with CT imaging, all these modalities expose the subject to ionizing radiation and cannot be applied serially without a compelling clinical need. Moreover, these nuclear imaging modalities suffer from poor spatial and temporal resolution.
The key role for HP 129Xe MRI is that it can enable non-invasive high-resolution imaging of all aspects of pulmonary structure and function. We have recently shown HP 129Xe MRI to visualize pulmonary ventilation with high resolution, as well as the ability to show abnormalities of the alveolar microstructure that are associated with the emphysema phenotype of COPD. We have also demonstrated the fundamentally new capability to directly visualize the uptake of 129Xe into the pulmonary capillary blood and tissues, which can provide an even more complete picture of pulmonary function by supplying regional gas exchange information.
Xenon is a noble gas that is not chemically altered by the body. A small fraction of the inhaled Xe is absorbed into the blood stream and has documented anesthetic effects at moderate concentrations. The levels of gas used in this protocol are within the previously derived safe limits for both animals and humans. The stable isotope 129Xe can be hyperpolarized, which is a means to enhance its gross MRI signal by a factor of ∼100,000. Such signal enhancement makes it possible to image the inhaled gas with high spatial and temporal resolution. Moreover, the properties of 129Xe enable images to be acquired with multiple forms of contrast including ventilation, lung microstructure, and regional gas exchange. Because 129Xe MRI uses no ionizing radiation, and only an inhaled gas contrast agent, it has the potential to be used in longitudinal studies to test the effects of therapy or monitor progression of disease noninvasively.
- Conditions
- Interstitial Lung Disease
- Being tested
- Hyperpolarized 129Xenon Gas
- Keywords
- Lung Disease, Pulmonary Disease, Diagnostic Imaging, MRI
- Medical subject headings
- Lung Diseases, Interstitial, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129Xenon GasDrug
Hyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The purpose of this trial is to examine the ability of HP 129Xe imaging to characterize the lung in healthy and diseased states. The safety endpoint for each subject is to record any adverse events as a measure of safety and tolerability. The technical endpoint for each subject is the acquisition of technically adequate HP 129Xe MR images.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 445 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Joseph Mammarappallil, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280994
- Sponsor's protocol ID
- Pro00025110
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2011
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kaushik SS, Kraft M, Wolber J, Kelly KT, McAdams HP, Driehuys B. Hyperpolarized Xe MR imaging of alveolar gas uptake in humans. PLoS One. 2010 Aug 16;5(8):e12192. doi: 10.1371/journal.pone.0012192.
PubMed 20808950Virgincar RS, Cleveland ZI, Kaushik SS, Freeman MS, Nouls J, Cofer GP, Martinez-Jimenez S, He M, Kraft M, Wolber J, McAdams HP, Driehuys B. Quantitative analysis of hyperpolarized 129Xe ventilation imaging in healthy volunteers and subjects with chronic obstructive pulmonary disease. NMR Biomed. 2013 Apr;26(4):424-35. doi: 10.1002/nbm.2880. Epub 2012 Oct 13.
PubMed 23065808Kaushik SS, Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kraft M, Auffermann W, Wolber J, McAdams HP, Driehuys B. Diffusion-weighted hyperpolarized 129Xe MRI in healthy volunteers and subjects with chronic obstructive pulmonary disease. Magn Reson Med. 2011 Apr;65(4):1154-65. doi: 10.1002/mrm.22697. Epub 2010 Dec 16.
PubMed 21413080Roos JE, McAdams HP, Kaushik SS, Driehuys B. Hyperpolarized Gas MR Imaging: Technique and Applications. Magn Reson Imaging Clin N Am. 2015 May;23(2):217-29. doi: 10.1016/j.mric.2015.01.003.
PubMed 25952516Kaushik SS, Freeman MS, Cleveland ZI, Davies J, Stiles J, Virgincar RS, Robertson SH, He M, Kelly KT, Foster WM, McAdams HP, Driehuys B. Probing the regional distribution of pulmonary gas exchange through single-breath gas- and dissolved-phase 129Xe MR imaging. J Appl Physiol (1985). 2013 Sep;115(6):850-60. doi: 10.1152/japplphysiol.00092.2013. Epub 2013 Jul 11.
PubMed 23845983He M, Kaushik SS, Robertson SH, Freeman MS, Virgincar RS, McAdams HP, Driehuys B. Extending semiautomatic ventilation defect analysis for hyperpolarized (129)Xe ventilation MRI. Acad Radiol. 2014 Dec;21(12):1530-41. doi: 10.1016/j.acra.2014.07.017. Epub 2014 Sep 26.
PubMed 25262951Kaushik SS, Freeman MS, Yoon SW, Liljeroth MG, Stiles JV, Roos JE, Foster W, Rackley CR, McAdams HP, Driehuys B. Measuring diffusion limitation with a perfusion-limited gas--hyperpolarized 129Xe gas-transfer spectroscopy in patients with idiopathic pulmonary fibrosis. J Appl Physiol (1985). 2014 Sep 15;117(6):577-85. doi: 10.1152/japplphysiol.00326.2014. Epub 2014 Jul 18.
PubMed 25038105Kaushik SS, Robertson SH, Freeman MS, He M, Kelly KT, Roos JE, Rackley CR, Foster WM, McAdams HP, Driehuys B. Single-breath clinical imaging of hyperpolarized (129)Xe in the airspaces, barrier, and red blood cells using an interleaved 3D radial 1-point Dixon acquisition. Magn Reson Med. 2016 Apr;75(4):1434-43. doi: 10.1002/mrm.25675. Epub 2015 May 18.
PubMed 25980630He M, Robertson SH, Kaushik SS, Freeman MS, Virgincar RS, Davies J, Stiles J, Foster WM, McAdams HP, Driehuys B. Dose and pulse sequence considerations for hyperpolarized (129)Xe ventilation MRI. Magn Reson Imaging. 2015 Sep;33(7):877-85. doi: 10.1016/j.mri.2015.04.005. Epub 2015 Apr 30.
PubMed 25936684Ebner L, He M, Virgincar RS, Heacock T, Kaushik SS, Freemann MS, McAdams HP, Kraft M, Driehuys B. Hyperpolarized 129Xenon Magnetic Resonance Imaging to Quantify Regional Ventilation Differences in Mild to Moderate Asthma: A Prospective Comparison Between Semiautomated Ventilation Defect Percentage Calculation and Pulmonary Function Tests. Invest Radiol. 2017 Feb;52(2):120-127. doi: 10.1097/RLI.0000000000000322.
PubMed 27662575He M, Driehuys B, Que LG, Huang YT. Using Hyperpolarized 129Xe MRI to Quantify the Pulmonary Ventilation Distribution. Acad Radiol. 2016 Dec;23(12):1521-1531. doi: 10.1016/j.acra.2016.07.014. Epub 2016 Sep 9.
PubMed 27617823Dahhan T, Kaushik SS, He M, Mammarappallil JG, Tapson VF, McAdams HP, Sporn TA, Driehuys B, Rajagopal S. Abnormalities in hyperpolarized (129)Xe magnetic resonance imaging and spectroscopy in two patients with pulmonary vascular disease. Pulm Circ. 2016 Mar;6(1):126-31. doi: 10.1086/685110.
PubMed 27162620Robertson SH, Virgincar RS, Bier EA, He M, Schrank GM, Smigla RM, Rackley C, McAdams HP, Driehuys B. Uncovering a third dissolved-phase 129 Xe resonance in the human lung: Quantifying spectroscopic features in healthy subjects and patients with idiopathic pulmonary fibrosis. Magn Reson Med. 2017 Oct;78(4):1306-1315. doi: 10.1002/mrm.26533. Epub 2016 Nov 8.
PubMed 28940334
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized 129Xe MR Imaging of the Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01280994
- Acronym / sponsor ID
- Pro00025110
- Conditions
- Interstitial Lung Disease
- Keywords
- Lung Disease, Pulmonary Disease, Diagnostic Imaging, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 445 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Jan 2011 (estimated)
- 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 purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Detailed description
Non-invasive imaging of pulmonary function is expected to provide critical insights that are needed to spur progress in characterizing and treating chronic pulmonary diseases. The current primary diagnostic measure is pulmonary function testing (PFT), which was introduced in the mid-19th century, yet remains the standard of care today. PFTs have the advantage of being non-invasive and widely available, but suffer from poor sensitivity and high variability. Thus, PFTs are ineffective in assessing therapeutic response or disease progression on reasonable time scales, given the frequent heterogeneity of disease and the lung's compensatory mechanisms.
It has long been appreciated that improving sensitivity requires assessing the lungs regionally. To this end, methods, such as computed tomography (CT), provide insights into lung structure, but lung function must be inferred. However, of greater concern is the high radiation dose associated with CT, which precludes frequent longitudinal follow-up imaging. Alternatively, regional imaging of both ventilation and perfusion is possible using nuclear medicine techniques such as planar scintigraphy, single photon computed tomography (SPECT), or positron emission tomography (PET). However, as with CT imaging, all these modalities expose the subject to ionizing radiation and cannot be applied serially without a compelling clinical need. Moreover, these nuclear imaging modalities suffer from poor spatial and temporal resolution.
The key role for HP 129Xe MRI is that it can enable non-invasive high-resolution imaging of all aspects of pulmonary structure and function. We have recently shown HP 129Xe MRI to visualize pulmonary ventilation with high resolution, as well as the ability to show abnormalities of the alveolar microstructure that are associated with the emphysema phenotype of COPD. We have also demonstrated the fundamentally new capability to directly visualize the uptake of 129Xe into the pulmonary capillary blood and tissues, which can provide an even more complete picture of pulmonary function by supplying regional gas exchange information.
Xenon is a noble gas that is not chemically altered by the body. A small fraction of the inhaled Xe is absorbed into the blood stream and has documented anesthetic effects at moderate concentrations. The levels of gas used in this protocol are within the previously derived safe limits for both animals and humans. The stable isotope 129Xe can be hyperpolarized, which is a means to enhance its gross MRI signal by a factor of ∼100,000. Such signal enhancement makes it possible to image the inhaled gas with high spatial and temporal resolution. Moreover, the properties of 129Xe enable images to be acquired with multiple forms of contrast including ventilation, lung microstructure, and regional gas exchange. Because 129Xe MRI uses no ionizing radiation, and only an inhaled gas contrast agent, it has the potential to be used in longitudinal studies to test the effects of therapy or monitor progression of disease noninvasively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Subject has a diagnosis of pulmonary dysfunction made by a physician
- No acute worsening of pulmonary function in the past 30 days
Key exclusion criteria (9 listed)
- Subject is less than 18 years old
- MRI is contraindicated based on responses to MRI screening questionaire
- Subject is pregnant or lactating
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
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 129Xenon GasHyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. | Drug | – |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 2
The purpose of this trial is to examine the ability of HP 129Xe imaging to characterize the lung in healthy and diseased states. The safety endpoint for each subject is to record any adverse events as a measure of safety and tolerability. The technical endpoint for each subject is the acquisition of technically adequate HP 129Xe MR images.
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 16 Jan 2026.
- Background: PubMed 20808950Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kaushik SS, Kraft M, Wolber J, Kelly KT, McAdams HP, Driehuys B. Hyperpolarized Xe MR imaging of alveolar gas uptake in humans. PLoS One. 2010 Aug 16;5(8):e12192. doi: 10.1371/journal.pone.0012192.
- Background: PubMed 23065808Virgincar RS, Cleveland ZI, Kaushik SS, Freeman MS, Nouls J, Cofer GP, Martinez-Jimenez S, He M, Kraft M, Wolber J, McAdams HP, Driehuys B. Quantitative analysis of hyperpolarized 129Xe ventilation imaging in healthy volunteers and subjects with chronic obstructive pulmonary disease. NMR Biomed. 2013 Apr;26(4):424-35. doi: 10.1002/nbm.2880. Epub 2012 Oct 13.
- Background: PubMed 21413080Kaushik SS, Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kraft M, Auffermann W, Wolber J, McAdams HP, Driehuys B. Diffusion-weighted hyperpolarized 129Xe MRI in healthy volunteers and subjects with chronic obstructive pulmonary disease. Magn Reson Med. 2011 Apr;65(4):1154-65. doi: 10.1002/mrm.22697. Epub 2010 Dec 16.
- Background: PubMed 25952516Roos JE, McAdams HP, Kaushik SS, Driehuys B. Hyperpolarized Gas MR Imaging: Technique and Applications. Magn Reson Imaging Clin N Am. 2015 May;23(2):217-29. doi: 10.1016/j.mric.2015.01.003.
- Results publication: PubMed 23845983Kaushik SS, Freeman MS, Cleveland ZI, Davies J, Stiles J, Virgincar RS, Robertson SH, He M, Kelly KT, Foster WM, McAdams HP, Driehuys B. Probing the regional distribution of pulmonary gas exchange through single-breath gas- and dissolved-phase 129Xe MR imaging. J Appl Physiol (1985). 2013 Sep;115(6):850-60. doi: 10.1152/japplphysiol.00092.2013. Epub 2013 Jul 11.
- Results publication: PubMed 25262951He M, Kaushik SS, Robertson SH, Freeman MS, Virgincar RS, McAdams HP, Driehuys B. Extending semiautomatic ventilation defect analysis for hyperpolarized (129)Xe ventilation MRI. Acad Radiol. 2014 Dec;21(12):1530-41. doi: 10.1016/j.acra.2014.07.017. Epub 2014 Sep 26.
- Results publication: PubMed 25038105Kaushik SS, Freeman MS, Yoon SW, Liljeroth MG, Stiles JV, Roos JE, Foster W, Rackley CR, McAdams HP, Driehuys B. Measuring diffusion limitation with a perfusion-limited gas--hyperpolarized 129Xe gas-transfer spectroscopy in patients with idiopathic pulmonary fibrosis. J Appl Physiol (1985). 2014 Sep 15;117(6):577-85. doi: 10.1152/japplphysiol.00326.2014. Epub 2014 Jul 18.
- Results publication: PubMed 25980630Kaushik SS, Robertson SH, Freeman MS, He M, Kelly KT, Roos JE, Rackley CR, Foster WM, McAdams HP, Driehuys B. Single-breath clinical imaging of hyperpolarized (129)Xe in the airspaces, barrier, and red blood cells using an interleaved 3D radial 1-point Dixon acquisition. Magn Reson Med. 2016 Apr;75(4):1434-43. doi: 10.1002/mrm.25675. Epub 2015 May 18.
- Results publication: PubMed 25936684He M, Robertson SH, Kaushik SS, Freeman MS, Virgincar RS, Davies J, Stiles J, Foster WM, McAdams HP, Driehuys B. Dose and pulse sequence considerations for hyperpolarized (129)Xe ventilation MRI. Magn Reson Imaging. 2015 Sep;33(7):877-85. doi: 10.1016/j.mri.2015.04.005. Epub 2015 Apr 30.
- Results publication: PubMed 27662575Ebner L, He M, Virgincar RS, Heacock T, Kaushik SS, Freemann MS, McAdams HP, Kraft M, Driehuys B. Hyperpolarized 129Xenon Magnetic Resonance Imaging to Quantify Regional Ventilation Differences in Mild to Moderate Asthma: A Prospective Comparison Between Semiautomated Ventilation Defect Percentage Calculation and Pulmonary Function Tests. Invest Radiol. 2017 Feb;52(2):120-127. doi: 10.1097/RLI.0000000000000322.
- Results publication: PubMed 27617823He M, Driehuys B, Que LG, Huang YT. Using Hyperpolarized 129Xe MRI to Quantify the Pulmonary Ventilation Distribution. Acad Radiol. 2016 Dec;23(12):1521-1531. doi: 10.1016/j.acra.2016.07.014. Epub 2016 Sep 9.
- Results publication: PubMed 27162620Dahhan T, Kaushik SS, He M, Mammarappallil JG, Tapson VF, McAdams HP, Sporn TA, Driehuys B, Rajagopal S. Abnormalities in hyperpolarized (129)Xe magnetic resonance imaging and spectroscopy in two patients with pulmonary vascular disease. Pulm Circ. 2016 Mar;6(1):126-31. doi: 10.1086/685110.
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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.
Joseph Mammarappallil, M.D. 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 129Xenon Gas in people with Interstitial Lung Disease, 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Jan 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?
Contact Jennifer Korzekwinski (919-681-7362, jennifer.korzekwinski@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Day 2). 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 NCT01280994, which also lists 13 linked publications.
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 16 Jan 2026.