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

Primary Purpose

Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hyperpolarized Xe129
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Subjects with Progressive Interstitial Lung Disease

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 16, 2020
    Last Updated
    September 6, 2022
    Sponsor
    University of Kansas Medical Center
    Collaborators
    Duke University, Children's Hospital Medical Center, Cincinnati, Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04677426
    Brief Title
    129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
    Official Title
    129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor withdrew Funding
    Study Start Date
    May 1, 2022 (Actual)
    Primary Completion Date
    August 1, 2022 (Actual)
    Study Completion Date
    August 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Kansas Medical Center
    Collaborators
    Duke University, Children's Hospital Medical Center, Cincinnati, Boehringer Ingelheim

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects with Progressive Interstitial Lung Disease
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyperpolarized Xe129
    Other Intervention Name(s)
    Xenon, HP 129Xe
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    RBC:Barrier Ratio
    Description
    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.
    Time Frame
    RBC:Barrier will be assessed at Baseline and at 6 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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