RecruitingPhase 2NCT06038630

129Xe MRI Cardiopulmonary

129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function

Sponsor

Bastiaan Driehuys

Enrollment

125 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria32

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
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
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)
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 Criteria11

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

Interventions

DRUGHyperpolarized 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.

OTHEROxygen Administration

Oxygen administration

Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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Visit

NCT06038630

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