ClinicalTrials.gg
RecruitingNCT06038630Updated Feb 4, 2026

129Xe MRI Cardiopulmonary

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

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Interstitial Lung Disease
  • Chronic Thromboembolic Pulmonary Hypertension
  • Acute Pulmonary Embolism
  • Anemia
  • Polycythemia
  • Dyspnea
03

In context

Lung Diseases, Interstitial

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

(Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial)

  1. Outpatients of either gender, age > 18
  2. Willing and able to give and adhere to visit/protocol (Consent must be given before any study procedures are performed.)
  3. Subject has no diagnosed pulmonary conditions
  4. Subject has not smoked in the previous 5 years
  5. Smoking history, if any, is less than or equal to 5 pack-years
  6. No history of using other inhaled products more than 1/week for > 1 year

Inclusion Criteria for Transfusion and Phlebotomy Patients:

  1. In-patient or outpatients of either sex, age > 18
  2. Willing and able to give informed consent and adhere to visit/protocol

And one of the following:

  1. Patients who are scheduled to receive a red cell transfusion for anemia.
  2. Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia
  3. Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above)

Inclusion Criteria for Oxygen Administration Patients:

  1. In-patient or outpatients of either sex, age > 18
  2. Willing and able to give informed consent and adhere to visit/protocol

And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy):

  1. 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

  2. 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

  3. Healthy Volunteer (criteria noted above)

Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients:

  1. In-patient or outpatients of either sex, age > 18
  2. Willing and able to give informed consent and adhere to visit/protocol

And one of the following categories (Acute or Chronic)

  1. Acute Pulmonary Embolism

    • Patients presenting with acute PE 24-48hrs post-admission
    • Willing to return after 3-6 months of anti-coagulation therapy

    OR

  2. 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

Exclusion Criteria for All subjects:

Subjects presenting with any of the following will not be included in the trial:

  1. MRI is based on responses to MRI screening questionnaire
  2. Subject is pregnant or lactating
  3. Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula
  4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  5. Subject has history of any known ventricular cardiac arrhythmia
  6. Subject has history of cardiac arrest within the last year
  7. Subject does not fit into 129Xe vest coil used for MRI
  8. Subject cannot hold his/her breath for 10 seconds
  9. Subject deemed unlikely to be able to comply with instructions during imaging
  10. 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
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Active comparator
    Transfusion and Phlebotomy Patients

    Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.

    Drug: Hyperpolarized Xe129

  • Active comparator
    Oxygen Administration Patients

    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

  • Active comparator
    Acute or Chronic Pulmonary Embolism Patients

    Individuals recently diagnosed with a blood clot in their lungs.

    Drug: Hyperpolarized Xe129

Interventions

  • 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.

  • OtherOxygen Administration

    Oxygen administration

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Sep 8, 2023
First posted
Sep 15, 2023
StartActual
Jan 12, 2024
Primary completionEst.
Jun 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Feb 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06038630
Lead sponsor
Bastiaan Driehuys
Responsible party
Bastiaan Driehuys (Professor of Radiology, Duke University) — Sponsor-investigator
First posted
Sep 15, 2023
Start date
Jan 12, 2024
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Feb 4, 2026

Study contacts

Bastiaan Driehuys, PhD
Contact
bastiaan.driehuys@duke.edu
919-684-7786
Joseph Mammarappallil, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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