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129Xe MRI Cardiopulmonary

Primary Purpose

Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension, Acute Pulmonary Embolism

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Xe129
Oxygen Administration
Sponsored by
Bastiaan Driehuys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, CTEPH, or Healthy): Interstitial Lung Disease Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Transfusion and Phlebotomy Patients

Oxygen Administration Patients

Acute or Chronic Pulmonary Embolism Patients

Arm Description

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

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 are a healthy volunteer.

Individuals recently diagnosed with a blood clot in their lungs.

Outcomes

Primary Outcome Measures

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.
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, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Change in RBC Oscillation Amplitude Post Therapy
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Bastiaan Driehuys
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT06038630
Brief Title
129Xe MRI Cardiopulmonary
Official Title
129Xe Gas Exchange MRI to Visualize Cardiopulmonary Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bastiaan Driehuys
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Chronic Thromboembolic Pulmonary Hypertension, Acute Pulmonary Embolism, Anemia, Polycythemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transfusion and Phlebotomy Patients
Arm Type
Active Comparator
Arm Description
Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.
Arm Title
Oxygen Administration Patients
Arm Type
Active Comparator
Arm Description
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 are a healthy volunteer.
Arm Title
Acute or Chronic Pulmonary Embolism Patients
Arm Type
Active Comparator
Arm Description
Individuals recently diagnosed with a blood clot in their lungs.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Xe129
Intervention Description
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
Other
Intervention Name(s)
Oxygen Administration
Intervention Description
Oxygen administration
Primary Outcome Measure Information:
Title
Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis
Description
The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.
Time Frame
Up to 5 days pre/post transfusion or apheresis
Title
Change in RBC (red blood cell) Chemical Shift After Oxygen Administration
Description
To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).
Time Frame
Baseline, 1 day
Title
Change in RBC Oscillation Amplitude Post Therapy
Description
Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.
Time Frame
Baseline, 3-6 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) 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, CTEPH, or Healthy): Interstitial Lung Disease Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bastiaan Driehuys, PhD
Phone
919-684-7786
Email
bastiaan.driehuys@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Mammarappallil, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cody Blanton
Phone
919-668-7575
Email
cody.blanton@duke.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Korzekwinski
Phone
919-681-7362
Email
jennifer.korzekwinski@duke.edu
First Name & Middle Initial & Last Name & Degree
Joseph Mammarappallil, MD
First Name & Middle Initial & Last Name & Degree
Bastiaan Driehuys, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.
IPD Sharing Time Frame
In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.
IPD Sharing Access Criteria
We are committed to making de-identified datasets and image analysis available to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.

Learn more about this trial

129Xe MRI Cardiopulmonary

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