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

Phase 2

Withdrawn

• Conditions: Idiopathic Pulmonary Fibrosis; Hypersensitivity Pneumonitis
• Interventions: Drug: Hyperpolarized Xe129

• Registration Number: NCT04677426
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-21
• Study Start: 2022-05-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with Progressive Interstitial Lung Disease	Hyperpolarized Xe129	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.

Primary Outcome Measures

Name	Time	Method
RBC:Barrier Ratio	RBC:Barrier will be assessed at Baseline and at 6 months.	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.