Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis

Early Phase 1

Not yet recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Hyperpolarized Xe129

• Registration Number: NCT06853145
• Lead Sponsor: University of Virginia

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Able to provide informed consent 18 years of age or greater Clinical diagnosis of IPF

Exclusion Criteria

• Continuous oxygen use at home
• Oxygen saturation less than 92% on the day of MRI procedure
• Pregnancy or lactation
• Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
• History of congenital cardiac disease, chronic renal failure, or cirrhosis. • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
• Inability to understand simple instructions or to hold still for approximately 10-15 seconds.
• History of respiratory infection within 2 weeks prior to the MR scan
• History of MI, stroke and/or poorly controlled hypertension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPF subjects	Hyperpolarized Xe129	IPF subjects will undergo Xe-129 MRI

Primary Outcome Measures

Name	Time	Method
Measuring the ventilation effect of HXe129 MRI for IPF subjects	Up to 24 hours post MR Imaging	We will initially use descriptive statistics to describe the hyperpolarized Xe129 MRI indices and visualize their distribution using histograms. Paired t-test will be used to examine differences between baseline and follow-up hyperpolarized Xe129 MRI indices. Given that SA2 is to prove feasibility of accomplishing the MRI procedure, we have purposely opted to not adjust for the multiple MRI measurements that will be obtained.

Secondary Outcome Measures

Name	Time	Method
Measuring the diffusion capacity of HXe 129 for IPF subjects	Up to 24 hours post MRI analysis	We will use linear mixed-effects model with random intercept and slope to determine the change in MRI indices over time between baseline and follow-up scans.

Trial Locations

Locations (1)

Snyder Building 480 Ray C. Hunt Drive; 🇺🇸 Charlottesville, Virginia, United States