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NCT Number: NCT06038630

129Xe MRI Cardiopulmonary

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Bastiaan Driehuys, PhD

SUB_INVESTIGATOR

Cody Blanton

CONTACT

[email protected]

919-668-7575

Jennifer Korzekwinski

CONTACT

[email protected]

919-681-7362

Joseph Mammarappallil, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperpolarized Xe129

Drug

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

Other

Oxygen administration

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bastiaan Driehuys, PhD

CONTACT

[email protected]

919-684-7786

Sponsors and collaborators

Lead sponsor

Bastiaan Driehuys

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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