Xenon MRI Pulm Hypertension

NCT04991454 | Terminated Phase 2 FDA Drug

• 1 other identifier: Pro00107613
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Lung Transplant; Xenon; MRI

Outcome Measures

Primary Outcomes (2)

• 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.

  5 years

• 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.

  5 years

Study Arms (2)

end-stage pulmonary hypertension .

OTHER

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

Drug: 129Xe Hyperpolarized

following pulmonary arterial hypertension subjects

OTHER

Following pulmonary arterial hypertension subjects upto 24 months

Drug: 129Xe Hyperpolarized

Interventions

129Xe Hyperpolarized DRUG

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.

end-stage pulmonary hypertension .; following pulmonary arterial hypertension subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bastiaan Driehuys: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sudarshan Rajagopal, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: August 5, 2021
• Study Start: September 1, 2021
• Primary Completion: May 14, 2025
• Study Completion: May 28, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)