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

NCT04677426 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 00146495
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Subjects with Progressive Interstitial Lung Disease

EXPERIMENTAL

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.

Drug: Hyperpolarized Xe129

Interventions

Hyperpolarized Xe129 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.

Also known as: Xenon, HP 129Xe

Subjects with Progressive Interstitial Lung Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Stable FVC over 2-year period as determined by study physician
• Unstable cardiac condition within 6 months of screening as determined by study physician

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Duke University: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Boehringer Ingelheim: collaborator

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Alveolitis, Extrinsic Allergic

Interventions

Xenon

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share