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

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04677426
Collaborator
Duke University (Other), Children's Hospital Medical Center, Cincinnati (Other), Boehringer Ingelheim (Industry)
40
Enrollment
1
Arm
6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyperpolarized Xe129
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Xenon
  • HP 129Xe

    		•

    Outcome Measures

    Primary Outcome Measures

    1. RBC:Barrier Ratio [RBC:Barrier will be assessed at Baseline and at 6 months.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT04677426
    Other Study ID Numbers:
    • 00146495
    First Posted:
    Dec 21, 2020
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumonia
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Alveolitis, Extrinsic Allergic
    Hypersensitivity

    Study Results

    No Results Posted as of Apr 14, 2022