Clinical trial NCT06853145: Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis
Official title: Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Hyperpolarized Xenon-129 gas with MRI
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: IPF subjects will be scan via MRI using Hyperpolarized Xenon-129 gas
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring the ventilation effect of HXe129 MRI for IPF subjects
timeFrame: Up to 24 hours post MR Imaging
Secondary outcomes:
measure: Measuring the diffusion capacity of HXe 129 for IPF subjects
timeFrame: Up to 24 hours post MRI analysis
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: Snyder Building 480 Ray C. Hunt Drive
state: Virginia
Study officials:
affiliation: University of Virginia
name: John Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: