Back to results

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Withdrawn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

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

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

Data Monitoring Committee

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs