NCT06853145

Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. The Investigator hypothesize hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time which will detect deficiencies related to perfusion in the lung.

Detailed description

Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. Idiopathic pulmonary fibrosis (IPF) is a subtype of interstitial lung disease (ILD) that can lead to chronic hypoxic and ventilatory respiratory failure and early death.1 While current treatments slow disease progression, they do not improve symptoms or quality of life and are often poorly tolerated due to significant side effect profiles. Therefore, there remains an unmet need for more tolerable therapies with an acceptable side effect profile that slows progression and improves patient-centered outcomes. Functional imaging is a promising tool for assessing treatment response in IPF. Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes like hospitalization and death have been traditional clinical trial endpoints in IPF. However, these endpoints are time and resource-consuming. Thus, there has been significant interest in using other trial endpoints, the most promising of which is lung imaging. The study group employed hyperpolarized xenon-129 magnetic resonance imaging (Xe129-MRI) to quantify and localize deficits in pulmonary ventilation and perfusion in chronic obstructive diseases. It has recently extended this to pulmonary fibrosis. However, to implement Xe129-MRI as an endpoint in a mechanistic clinical trial, the investigator proposes to demonstrate the feasibility of employing this procedure over time in patients with IPF. The investigator hypothesizes that hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time, which will detect deficiencies related to perfusion in the lung.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Hyperpolarized Xe129	Hyperpolarized Xe129-MRI: Patients will undergo hyperpolarized Xe129-MRI at the University of Virginia Radiology Imaging Core (Charlottesville, VA, USA). The entire procedure visit takes approximately 3 hours based on our team's experience.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-02-28
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study