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Withdrawn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
About this trial
This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis
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
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
NCT ID
NCT04677426
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
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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