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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

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