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

NCT ID: NCT04677426

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-08-01

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.

Conditions

Idiopathic Pulmonary Fibrosis; Hypersensitivity Pneumonitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subjects with Progressive Interstitial Lung Disease

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.

Group Type: EXPERIMENTAL

Hyperpolarized Xe129

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Xenon; HP 129Xe

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

00146495

Identifier Type: -

Identifier Source: org_study_id