A Phase 2 interventional study of Hyperpolarized Xe129 and Oxygen Administration in Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension and Acute Pulmonary Embolism, sponsored by Bastiaan Driehuys. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Bastiaan Driehuys · Phase 2, Interventional, and Diagnostic
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.
This study focuses on the markers that are derived from the interaction of 129Xe with pulmonary capillary red blood cells (RBCs). Specifically, the investigators focus on RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift.
In addition to healthy volunteers, the population to be studied will consist of patients scheduled to undergo either transfusion or phlebotomy, those with dyspnea, those with a physician diagnosis of interstitial lung disease (ILD), idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonias (NSIP), chronic hypersensitivity pneumonitis (cHP), and sarcoid, as well as those with either chronic thromboembolic pulmonary hypertension (CTEPH) and acute pulmonary embolism.
680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.
This study's planned enrollment of 125 is above the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.
Browse Lung Diseases, Interstitial studies →Bastiaan Driehuys is the lead sponsor of 18 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)
Inclusion Criteria for Transfusion and Phlebotomy Patients:
And one of the following:
Inclusion Criteria for Oxygen Administration Patients:
And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):
Interstitial Lung Disease or Dyspnea
OR
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
OR
Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients:
And one of the following categories (Acute or Chronic)
Acute Pulmonary Embolism
OR
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Exclusion Criteria for All subjects:
Subjects presenting with any of the following will not be included in the trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.
Drug: Hyperpolarized Xe129
Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer.
Drug: Hyperpolarized Xe129 · Other: Oxygen Administration
Individuals recently diagnosed with a blood clot in their lungs.
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.
Oxygen administration
Change in RBC to Membrane Ratio Pre and 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.
Time frame: Up to 5 days pre/post transfusion or apheresis
Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
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).
Time frame: Baseline, 1 day
Change in RBC Oscillation Amplitude Post Therapy
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
Time frame: Baseline, 3-6 months post-treatment
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 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 will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.
Access criteria: We are committed to making de-identified datasets and image analysis available 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.
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jun 2028, 53 months after the start.
Of 53 phase 2 interventional studies under Lung Diseases, Interstitial, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 71. This study's planned 53 months is above that.
How these figures are worked out, and which studies are left out of them.
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Bastiaan Driehuys