Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

Study Overview
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Brief Summary
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The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).

Official Title
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Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

Conditions
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Interstitial Lung Diseases

Intervention / Treatment
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* Drug: Hyperpolarized 129Xe


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion Criteria for Healthy Volunteers Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: Outpatients of either gender, age greater than or equal to 18 years Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.) Subject has no diagnosed pulmonary conditions Subject has not smoked in the previous 5 years Smoking history, if any, is less than or equal to 5 pack-years No history of using other inhaled products more than 1 time per week for > 1 year Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial: Subject is less than 18 years old MRI is contraindicated based on responses to MRI screening questionnaire Subject is pregnant or lactating Resting oxygen saturation on room air <90% Respiratory illness of a bacterial or viral etiology within 30 days of MRI Subject has history of any known ventricular cardiac arrhythmia Subject has history of cardiac arrest within the last year Subject does not fit into Xe vest coil used for MRI 129 Subject cannot hold his/her breath for 15 seconds Subject deemed unlikely to be able to comply with instructions during imaging Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements Inclusion/Exclusion Criteria for Subjects with Interstitial Lung Disease Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the trial: Outpatients of either gender, age greater than or equal to 18 years Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.) Clinical diagnosis of Interstitial Lung Disease made by a board certified pulmonologist using established criteria. We will not exclude individuals based on ILD type or severity of disease with the exception of the below criteria Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial: Subject is less than 18 years old MRI is contraindicated based on responses to MRI screening questionnaire Subject is pregnant or lactating Resting oxygen saturation <90% on supplemental oxygen Respiratory illness of a bacterial or viral etiology within 30 days of MRI Subject has history of any known ventricular cardiac arrhythmia. Subject has history of cardiac arrest within the last year Subject does not fit into Xe vest coil used for MRI 129 Subject cannot hold his/her breath for 15 seconds Subject deemed unlikely to be able to comply with instructions during imaging Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with Interstitial Lung Disease<br> | Drug: Hyperpolarized 129Xe<br>* Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.<br>|
| Active Comparator: Healthy Volunteers<br> | Drug: Hyperpolarized 129Xe<br>* Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracic cavity volume measured in liters. |  | 4 years | 
| RBC/barrier signal ratio (unitless). |  | 4 years | 
| Coefficient of repeatability of RBC/barrier signal ratio (unitless). |  | 4 years | 
| Echo time to separate RBC and barrier signals by 90 degrees (ms). |  | 4 years | 
| Population-wide RBC/barrier signal ratio (unitless). |  | 4 years |