Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis

NCT06853145 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: HSR240022
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Hyperpolarized Xenon-129 gas with MRI

Outcome Measures

Primary Outcomes (1)

• Measuring the ventilation effect of HXe129 MRI for IPF subjects

  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.

  Up to 24 hours post MR Imaging

Secondary Outcomes (1)

• Measuring the diffusion capacity of HXe 129 for IPF subjects

  Up to 24 hours post MRI analysis

Study Arms (1)

IPF subjects

OTHER

IPF subjects will undergo Xe-129 MRI

Drug: Hyperpolarized Xe129

Interventions

Hyperpolarized Xe129 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.

Also known as: 129 HXe MRI

IPF subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Snyder Building 480 Ray C. Hunt Drive

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• John Kim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roselove Asare, MA

CONTACT

4342436074; rnn3b@uvahealth.org

Carol Bampoe, BS

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: IPF subjects will be scan via MRI using Hyperpolarized Xenon-129 gas

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: February 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)