129Xe MRI Cardiopulmonary

NCT ID: NCT06038630

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2028-06-30

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transfusion and Phlebotomy Patients

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

Group Type: ACTIVE_COMPARATOR

Hyperpolarized Xe129

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Hyperpolarized Xe129

Intervention Type: 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

Intervention Type: OTHER

Oxygen administration

Acute or Chronic Pulmonary Embolism Patients

Individuals recently diagnosed with a blood clot in their lungs.

Group Type: ACTIVE_COMPARATOR

Hyperpolarized Xe129

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Oxygen Administration

Oxygen administration

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Outpatients of either gender, age > 18

2. Willing and able to give informed consent 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

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

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)

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

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

1. MRI is contraindicated 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Bastiaan Driehuys

OTHER

Sponsor Role: lead

Responsible Party

Bastiaan Driehuys

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph Mammarappallil, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bastiaan Driehuys, PhD

Role: CONTACT

bastiaan.driehuys@duke.edu

919-684-7786

Facility Contacts

Cody Blanton

Role: primary

cody.blanton@duke.edu

919-668-7575

Jennifer Korzekwinski

Role: backup

jennifer.korzekwinski@duke.edu

919-681-7362

Other Identifiers

Pro00113114

Identifier Type: -

Identifier Source: org_study_id