NCT06038630 · Bastiaan Driehuys
129Xe MRI Cardiopulmonary
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Hyperpolarized Xe129
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds.
OTHER
Oxygen Administration
Oxygen administration
Primary outcome measures
Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
Time frame: Up to 5 days pre/post transfusion or apheresis
The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.
Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
Time frame: Baseline, 1 day
To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, those with dyspnea, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Change in RBC Oscillation Amplitude Post Therapy
Time frame: Baseline, 3-6 months post-treatment
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Healthy Volunteers: (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 Inclusion Criteria for Transfusion and Phlebotomy Patients:
- 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) Inclusion Criteria for Oxygen Administration Patients:
- 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) Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients:
- 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
Exclusion criteria
- for All subjects: 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
- 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 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
- 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
Where
- Durham, North Carolina
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations