129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study

This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.

Study Overview

• Status: Withdrawn
• Conditions: Idiopathic Pulmonary Fibrosis; Hypersensitivity Pneumonitis
• Intervention / Treatment: Drug: Hyperpolarized Xe129

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults > 18 years of age
• Diagnosis of progressive chronic HP, IPF as determined by MDD discussion (historical or during screening period) OR normal control (no history of known lung disease, no abnormal parenchymal or airway findings on CT examination and no values outside of the normal for FVC, FEV1, TLC, and DLCO.)
• FVC % Predicted >45%
• DLCO % Predicted >30%
• Progressive lung disease as defined by one of the following criteria within 24 months of screening visit
• Relative decline in the FVC ≥ 10% of the predicted value
• Relative decline in the FVC of ≥ 5% - < 10% of the predicted value and worsening of respiratory symptoms
• Relative decline in the FVC of ≥ 5% - < 10% of the predicted value and an increased extent of fibrosis on prior clinical high-resolution CT
• Worsening of respiratory symptoms and an increased extent of fibrosis on high-resolution CT.

Exclusion Criteria:

• Stable FVC over 2-year period as determined by study physician
• Unstable cardiac condition within 6 months of screening as determined by study physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with Progressive Interstitial Lung Disease; Assess the intra-visit reliability and sensitivity to progression of 129Xe MR imaging measurements using a standardized imaging protocol in subjects with IPF and cHP.	Drug: Hyperpolarized Xe129; Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to assess patients with cHP and IPF.; Other Names: Xenon; HP 129Xe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC:Barrier Ratio	RBC:Barrier ratio will be determined using 129 Xenon MRI in 2 successive scans on two separate days 6 months apart. Same-day Repeated measures will be used to assess reliability of RBC:Barrier. Data acquired at 6 months will be correlated with FVC.	RBC:Barrier will be assessed at Baseline and at 6 months.

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Boehringer Ingelheim; Duke University; Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Respiratory Hypersensitivity; Lung Diseases, Interstitial; Hypersensitivity; Pneumonia; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Alveolitis, Extrinsic Allergic
• Other Study ID Numbers: 00146495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No