Status:
WITHDRAWN
129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Duke University
Children's Hospital Medical Center, Cincinnati
Conditions:
Idiopathic Pulmonary Fibrosis
Hypersensitivity Pneumonitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 perf...
Eligibility Criteria
Inclusion
- 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
- Stable FVC over 2-year period as determined by study physician
- Unstable cardiac condition within 6 months of screening as determined by study physician
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04677426
Start Date
May 1 2022
End Date
August 1 2022
Last Update
September 10 2022
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