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

University of Kansas

Status and phase: Withdrawn; Phase 2

Conditions: Hypersensitivity Pneumonitis; Idiopathic Pulmonary Fibrosis

Treatments: Drug: Hyperpolarized Xe129

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04677426

00146495

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Subjects with Progressive Interstitial Lung Disease

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized Xe129