NCT06038630RecruitingPhase 2
129Xe MRI Cardiopulmonary
129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- First submitted
- 8 Sept 2023
- Start date
- 12 Jan 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Bastiaan Driehuys
- NCT number
- NCT06038630
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 125
- From 12 Jan 2024 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Other
- Subjects presenting with any of the following will not be included in the trial:
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 10 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
Who the study is looking for
- (Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)
- Outpatients of either gender, age \> 18
- Willing and able to give informed consent and adhere to visit/protocol (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
- No history of using other inhaled products more than 1/week for \> 1 year
- In-patient or outpatients of either sex, age \> 18
- Willing and able to give informed consent and adhere to visit/protocol
- And one of the following:
- Patients who are scheduled to receive a red cell transfusion for anemia.
- Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia
- Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above)
- In-patient or outpatients of either sex, age \> 18
- Willing and able to give informed consent and adhere to visit/protocol
- And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):
- Interstitial Lung Disease or Dyspnea
- Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea
- OR
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
- Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
- OR
- Healthy Volunteer (criteria noted above)
- In-patient or outpatients of either sex, age \> 18
- Willing and able to give informed consent and adhere to visit/protocol
- And one of the following categories (Acute or Chronic)
- Acute Pulmonary Embolism
- Patients presenting with acute PE 24-48hrs post-admission
- Willing to return after 3-6 months of anti-coagulation therapy
- OR
- Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation
- Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.