Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hyperpolarized 129Xenon gas · 1 trial · 1 indication
Percent change in pulmonary gas exchange (percent change in abnormal RBC percentage - calculated as: 100\*(value at 3 hours - value at baseline)/value at baseline) in patients with PH treated with inhaled prostacyclin.
| Arm | Type | Description |
|---|---|---|
| Pulmonary Hypertension Patients on Inhaled Prostacyclin | EXPERIMENTAL | 10 subjects will Pulmonary Hypertension on a stable dose of Inhaled Prostacyclin for treatment of PH. |
| Name | Type | Description |
|---|---|---|
| Hyperpolarized 129Xenon gas | DRUG | Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment. |
Inclusion Criteria: Patients with known Pulmonary Hypertension on treatment with inhaled prostacyclin (iTRE) that are followed in the Duke Pulmonary Vascular Disease Clinic. Inclusion criteria includes: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg in the absence of significant concomitant left heart ...
Hyperpolarized 129Xenon gas is an investigational imaging agent being studied for use in pulmonary vascular disease. It is used in magnetic resonance imaging (MRI) to assess response to inhaled prostacyclin therapy. The gas is inhaled and its distribution in the lungs is visualized to evaluate treatment effects.
Hyperpolarized 129Xenon gas works by being inhaled and then detected using MRI. The hyperpolarization enhances the MRI signal, allowing visualization of gas distribution in the lungs. This provides a measure of ventilation and can help assess changes in pulmonary vascular function in response to treatment.
Hyperpolarized 129Xenon gas is being developed by United Therapeutics Corporation (NASDAQ: UTHR). The company is conducting clinical research to evaluate its use in pulmonary vascular disease.
Hyperpolarized 129Xenon gas is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. A Phase 2 trial has been completed to assess its use in pulmonary vascular disease.
Hyperpolarized 129Xenon gas has been studied in one completed Phase 2 trial, NCT03367312, titled "Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI." The trial enrolled 11 participants with pulmonary vascular disease in the United States and was not randomized or blinded.