129Xe MRI Cardiopulmonary

Anemia Clinical Trial

Official title:

129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038630
• Other study ID #: Pro00113114
• Status: Recruiting
• Phase: Phase 2
• Start date: January 12, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Bastiaan Driehuys, PhD
• Phone: 919-684-7786
• Email: bastiaan.driehuys[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Other:
• Oxygen Administration
Oxygen administration

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Bastiaan Driehuys	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 days pre/post transfusion or apheresis
Primary	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).	Baseline, 1 day
Primary	Change in RBC Oscillation Amplitude Post Therapy	Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.	Baseline, 3-6 months post-treatment