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

Interstitial Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855305
• Other study ID #: Pro00107570
• Secondary ID: R01HL126771
• Status: Recruiting
• Phase: Phase 2
• Start date: November 12, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Bastiaan Driehuys, PhD
• Phone: 919-684-7786
• Email: bastiaan.driehuys[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 147
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Hyperpolarized 129Xe
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Iowa	Iowa City	Iowa

Sponsors (5)

Lead Sponsor	Collaborator
Bastiaan Driehuys	Children's Hospital Medical Center, Cincinnati, National Heart, Lung, and Blood Institute (NHLBI), University of Cincinnati, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

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