Clinical trial NCT04855305: Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
Official title: Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Interstitial Lung Diseases
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Children's Hospital Medical Center, Cincinnati
name: University of Cincinnati
name: University of Iowa
First posted: 2021-04-22
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: 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:

1. Outpatients of either gender, age greater than or equal to 18 years
2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. Subject has no diagnosed pulmonary conditions
4. Subject has not smoked in the previous 5 years
5. Smoking history, if any, is less than or equal to 5 pack-years
6. 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:

1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation on room air \<90%
5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
6. Subject has history of any known ventricular cardiac arrhythmia
7. Subject has history of cardiac arrest within the last year
8. Subject does not fit into Xe vest coil used for MRI 129
9. Subject cannot hold his/her breath for 15 seconds
10. Subject deemed unlikely to be able to comply with instructions during imaging
11. 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:

1. Outpatients of either gender, age greater than or equal to 18 years
2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.)
3. 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:

1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI screening questionnaire
3. Subject is pregnant or lactating
4. Resting oxygen saturation \<90% on supplemental oxygen
5. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
6. Subject has history of any known ventricular cardiac arrhythmia.
7. Subject has history of cardiac arrest within the last year
8. Subject does not fit into Xe vest coil used for MRI 129
9. Subject cannot hold his/her breath for 15 seconds
10. Subject deemed unlikely to be able to comply with instructions during imaging
11. 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

Primary outcomes:
measure: Thoracic cavity volume measured in liters.
timeFrame: 4 years
measure: RBC/barrier signal ratio (unitless).
timeFrame: 4 years
measure: Coefficient of repeatability of RBC/barrier signal ratio (unitless).
timeFrame: 4 years
measure: Echo time to separate RBC and barrier signals by 90 degrees (ms).
timeFrame: 4 years
measure: Population-wide RBC/barrier signal ratio (unitless).
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Duke University
name: Joseph Mammarappallil, MD
role: PRINCIPAL_INVESTIGATOR
References: