Xenon MRI breathes new life into lung disease detection
NCT ID NCT04991454
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study explored whether a special type of MRI using inhaled xenon gas could detect changes in the small blood vessels of the lungs in people with pulmonary hypertension. The goal was to see if this imaging method could track disease progression or response to treatment. However, the trial was terminated early and only enrolled 12 participants, so the findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hyperpolarized xenon gas
- What this could lead to
- If successful, this could provide a new, non-invasive way to monitor lung blood vessel health in pulmonary hypertension patients.
- What could go wrong
- The trial was terminated early and enrolled only 12 people, so results are very limited. It is unclear if the technique will be reliable or useful in practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria of Cohort 1 Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Outpatients of either gender, Age 18-75 2. Awaiting a lung transplant 3. Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH), 3 (PH due to chronic lung disease, 4 (PH due to pulmonary artery obstructions), or 5 (PH due to miscellaneous causes) 4. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). 5. Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria of Cohort 1 Subjects presenting with any of the following will not be included in the trials: 1. Moderate to severe heart disease (LVEF \<45%, Severe LV hypertrophy, Moderate to severe valvular disease) 2. PH due to schistosomiasis 3. Active cancer 4. Sickle cell anemia 5. Prisoners and pregnant women will not be approached for the study 6. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine) 7. 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 Criteria of Cohort 2 Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Treatment naïve or treatment started within the last 3 months 2. Outpatients of either gender, Age 18-75 3. WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) \> 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU) 4. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). 5. Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria of Cohort 2 Subjects presenting with any of the following will not be included in the trials: 1. Sarcoidosis 2. Active cancer 3. Sickle cell anemia 4. Liver disease (Childs-Pugh class C) 5. Any conditions that prevent the performance of 129Xe MRI scans. 6. Prisoners and pregnant women will not be approached for the study. 7. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine). 8. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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