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Xenon MRI Pulm Hypertension (Jupiter PH)

Primary Purpose

Pulmonary Hypertension, Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
129Xe Hyperpolarized
Sponsored by
Bastiaan Driehuys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring Lung Transplant, Xenon, MRI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria of Cohort 1

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Outpatients of either gender, Age 18-75
  2. Awaiting a lung transplant
  3. Diagnosis of Group 1 PH using the criteria from previous clinical trials (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 WU, pulmonary capillary wedge pressure ≤ 15 mmHg)
  4. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
  5. Women of childbearing potential must have a negative urine pregnancy test before MRI

Exclusion Criteria of Cohort 1

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

  1. Pulmonary Veno-occlusive disease or Porto-pulmonary hypertension
  2. Moderate to severe heart disease (LVEF <45%, Severe LV hypertrophy, Moderate to severe valvular disease)
  3. PH due to schistosomiasis
  4. Sarcoidosis
  5. Active cancer
  6. Sickle cell anemia
  7. Liver disease (Childs-Pugh class C)
  8. Prisoners and pregnant women will not be approached for the study
  9. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
  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

Inclusion Criteria of Cohort 2

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Treatment naïve or treatment started within the last 3 months
  2. Outpatients of either gender, Age 18-75
  3. WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)
  4. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
  5. Women of childbearing potential must have a negative urine pregnancy test before MRI

Exclusion Criteria of Cohort 2

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

  1. Sarcoidosis
  2. Active cancer
  3. Sickle cell anemia
  4. Liver disease (Childs-Pugh class C)
  5. Any conditions that prevent the performance of 129Xe MRI scans.
  6. Prisoners and pregnant women will not be approached for the study.
  7. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
  8. 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 CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

end-stage pulmonary hypertension .

following pulmonary arterial hypertension subjects

Arm Description

subjects with end-stage PH that currently on the waitlist for lung transplant

Following pulmonary arterial hypertension subjects upto 24 months

Outcomes

Primary Outcome Measures

pulmonary vascular remodeling
The study team will determine whether the correlation between Red Blood Cell Signal from Xenon MRI to pathologic scoring of pulmonary vascular remodeling from histopathology is statistically significant.
Red Blood Cell Signal from Xenon MRI
We will determine whether the correlation between Red Blood Cell Signal from Xenon MRI to six minute walk distance, tricuspid annular plane excursion and right ventricular systolic pressure in longitudinal follow-up of PAH patients is statistically significant.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2021
Last Updated
November 15, 2022
Sponsor
Bastiaan Driehuys
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1. Study Identification

Unique Protocol Identification Number
NCT04991454
Brief Title
Xenon MRI Pulm Hypertension
Acronym
Jupiter PH
Official Title
Xenon MRI in Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bastiaan Driehuys

4. Oversight

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

5. Study Description

Brief Summary
The overall objective outlined in this study is to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is associated with changes in gas exchange physiology and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.
Detailed Description
In aim 1, the study team will compare 129Xe MRI signatures to lung explant pathology, cellular identity from single-cell RNA sequencing, and cellular phenotypes in gas exchange defects to areas that are spared, which the team will hypothesize are exposed to lower levels of hemodynamic shear stress. This will be done by performing 129Xe MRI scans in fifteen subjects (cohort 1) with PAH awaiting a lung transplant, followed by a pathologic assessment (with usual histopathology and single cell RNA sequencing) of the subject's explanted lung after transplant. The study team expect that areas of proliferation and fibrosis will correlate with 129Xe MRI gas exchange and spectroscopic defects In aim 3, The study team will test whether directly monitoring lung pathology with 129Xe MRI will provide additional prognostic information to standard-of-care clinical monitoring in 45 subjects (cohort 2). At 6-month follow-up appointments, standard-of-care assessments including labs, echocardiography, and six-minute walk distance and 129Xe MRI will be collected. The study team expect that In aim 1, the study team will compare 129Xe MRI signatures to lung explant pathology, cellular identity from single-cell RNA sequencing, and cellular phenotypes in gas exchange defects to areas that are spared, which the study team hypothesizes are exposed to lower levels of hemodynamic shear stress. This will be done by performing 129Xe MRI scans in fifteen subjects (cohort 1) with PAH awaiting a lung transplant, followed by a pathologic assessment (with usual histopathology and single-cell RNA sequencing) of the subject's explanted lung after transplant. The study team expect that areas of proliferation and fibrosis will correlate with 129Xe MRI gas exchange and spectroscopic defects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Pulmonary Arterial Hypertension
Keywords
Lung Transplant, Xenon, MRI

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
end-stage pulmonary hypertension .
Arm Type
Other
Arm Description
subjects with end-stage PH that currently on the waitlist for lung transplant
Arm Title
following pulmonary arterial hypertension subjects
Arm Type
Other
Arm Description
Following pulmonary arterial hypertension subjects upto 24 months
Intervention Type
Drug
Intervention Name(s)
129Xe Hyperpolarized
Intervention Description
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), as is the case for all protocols currently carried out under IND 109,490.
Primary Outcome Measure Information:
Title
pulmonary vascular remodeling
Description
The study team will determine whether the correlation between Red Blood Cell Signal from Xenon MRI to pathologic scoring of pulmonary vascular remodeling from histopathology is statistically significant.
Time Frame
5 years
Title
Red Blood Cell Signal from Xenon MRI
Description
We will determine whether the correlation between Red Blood Cell Signal from Xenon MRI to six minute walk distance, tricuspid annular plane excursion and right ventricular systolic pressure in longitudinal follow-up of PAH patients is statistically significant.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria of Cohort 1 Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: Outpatients of either gender, Age 18-75 Awaiting a lung transplant Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH), 3 (PH due to chronic lung disease, 4 (PH due to pulmonary artery obstructions), or 5 (PH due to miscellaneous causes) Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria of Cohort 1 Subjects presenting with any of the following will not be included in the trials: Moderate to severe heart disease (LVEF <45%, Severe LV hypertrophy, Moderate to severe valvular disease) PH due to schistosomiasis Active cancer Sickle cell anemia Prisoners and pregnant women will not be approached for the study Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine) 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 Inclusion Criteria of Cohort 2 Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: Treatment naïve or treatment started within the last 3 months Outpatients of either gender, Age 18-75 WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU) Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed). Women of childbearing potential must have a negative urine pregnancy test before MRI Exclusion Criteria of Cohort 2 Subjects presenting with any of the following will not be included in the trials: Sarcoidosis Active cancer Sickle cell anemia Liver disease (Childs-Pugh class C) Any conditions that prevent the performance of 129Xe MRI scans. Prisoners and pregnant women will not be approached for the study. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine). 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
David Ptashnik, MS
Phone
919-668-2642
Email
david.ptashnik@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudarshan Rajagopal, MD, PhD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ptashnik
Phone
919-668-2642
Email
david.ptashnik@duke.edu
First Name & Middle Initial & Last Name & Degree
Sudarshan Rajagopal, MD
First Name & Middle Initial & Last Name & Degree
Bastiann Driehays, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Xenon MRI Pulm Hypertension

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