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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04677426
• Other study ID #: 00146495
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Idiopathic Pulmonary Fibrosis
• Pneumonia
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Boehringer Ingelheim, Children's Hospital Medical Center, Cincinnati, Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.