Recruiting
Phase 2

Xenon MRI

Sponsor:

Bastiaan Driehuys

Code:

NCT04991454

Conditions

Pulmonary Hypertension

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

129Xe Hyperpolarized

Study Details

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.

Conditions

Pulmonary Hypertension

Pulmonary Arterial Hypertension

Study ID

NCT04991454

Start date

Sep 1, 2021

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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)
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. Moderate to severe heart disease (LVEF <45%, Severe LV hypertrophy, Moderate to severe valvular disease)
2. PH due to schistosomiasis
3. Active cancer
4. Sickle cell anemia
5. Prisoners and pregnant women will not be approached for the study
6. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
7. 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: end-stage pulmonary hypertension .

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

other: following pulmonary arterial hypertension subjects

Following pulmonary arterial hypertension subjects upto 24 months

Interventions

129Xe Hyperpolarized

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

  • pulmonary vascular remodeling [ Time Frame: 5 years ]
  • Red Blood Cell Signal from Xenon MRI [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Sudarshan Rajagopal, MD

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Lung Transplant
  • Xenon
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bastiaan Driehuys on 2026-08-10.