Using 129Xe MRI to study lung and blood conditions

129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

This study is testing how a special MRI using 129Xe gas can help us understand lung and blood conditions better by looking at healthy people and those with specific lung diseases.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06038630 on ClinicalTrials.gov

What this trial studies

This NIH-sponsored study aims to characterize three biomarkers derived from 129Xe gas exchange MRI to understand their changes in response to medical interventions. The focus is on the interaction of 129Xe with pulmonary capillary red blood cells, specifically examining RBC transfer MRI, cardiogenic oscillations in the 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift. The study will include healthy volunteers as well as patients with various pulmonary conditions, including interstitial lung disease and chronic thromboembolic pulmonary hypertension, who are scheduled for transfusion or phlebotomy.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with interstitial lung disease, chronic thromboembolic pulmonary hypertension, or those scheduled for transfusion or phlebotomy.

Not a fit: Patients with no diagnosed pulmonary conditions or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with lung and blood disorders.

How similar studies have performed: Other studies using hyperpolarized gas MRI have shown promise in characterizing lung function, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria for Healthy Volunteers:

(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 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

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 for All subjects:

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

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Joseph Mammarappallil, MD — Duke University
• Study coordinator: Bastiaan Driehuys, PhD

Conditions: Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension, Acute Pulmonary Embolism, Anemia, Polycythemia, Dyspnea