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RecruitingPhase 2

Xenon MRI Pulm Hypertension

Xenon MRI in Pulmonary Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses xenon MRI scans to learn how changes in lung blood vessels affect blood flow and how gases move through the lungs. It also tracks changes as disease gets worse or with treatment. It is for adults ages 18–75 with certain types of pulmonary hypertension, or high blood pressure in the lungs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Ages 18–75 and receiving care without staying in the hospital.
  • Both groups: Must agree to join before study tests and follow the study visit schedule.
  • Both groups: Women who could become pregnant must have a negative urine pregnancy test before MRI.
  • Group 1: Must be waiting for a lung transplant.
  • Group 1: Must have high blood pressure in the lung arteries confirmed by a heart catheter test. Allowed types include PAH and types caused by long-term lung disease, blocked lung arteries, or other causes.
  • Group 1: Heart testing must show average lung artery pressure of at least 25 mmHg, resistance to blood flow of at least 3 WU, and wedge pressure of 15 mmHg or less.
  • Group 2: Must have PAH with symptoms that limit physical activity, and have not started treatment or started within the past 3 months.
  • Group 2: Heart testing must show average lung artery pressure above 20 mmHg, resistance to blood flow of at least 3 WU, and wedge pressure of 15 mmHg or less.

Who can't join

  • Both groups: Active cancer or sickle cell anemia, an inherited red blood cell disease.
  • Both groups: Pregnant people and prisoners cannot join.
  • Both groups: Cannot safely have the MRI scan, such as due to metal in the eye, fear of tight spaces, or trouble lying flat on the back.
  • Both groups: A medical or mental health condition that the study doctor thinks could make joining unsafe or prevent following study rules.
  • Group 1: Moderate to severe heart disease, including weak heart pumping, major thickening of the heart muscle, or moderate to severe heart valve disease.
  • Group 1: Lung high blood pressure caused by schistosomiasis, a parasite infection.
  • Group 2: Sarcoidosis, a disease that causes patches of swelling in the body.
  • Group 2: Severe liver disease called Child-Pugh class C.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NC