Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis

NCT ID: NCT06853145

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-12-31

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IPF subjects

IPF subjects will undergo Xe-129 MRI

Group Type: OTHER

Hyperpolarized Xe129

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

129 HXe MRI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

John Kim, MD, MS

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

Snyder Building 480 Ray C. Hunt Drive

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roselove Asare, MA

Role: CONTACT

rnn3b@uvahealth.org

4342436074

Carol Bampoe, BS

Role: CONTACT

Facility Contacts

Roselove Asare, MA

Role: primary

rnn3b@uvahealth.org

434-243-6074

Carol Bampoe, BS

Role: backup

cb3ff@uvahealth.org

4342439634

Other Identifiers

HSR240022

Identifier Type: -

Identifier Source: org_study_id