Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
Primary Purpose
Interstitial Lung Diseases
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 129Xe
Sponsored by
About this trial
This is an interventional diagnostic trial for Interstitial Lung Diseases
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:
- 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
Sites / Locations
- University of IowaRecruiting
- Duke University Medical CenterRecruiting
- University of CincinnatiRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with Interstitial Lung Disease
Healthy Volunteers
Arm Description
Outcomes
Primary Outcome Measures
Thoracic cavity volume measured in liters.
RBC/barrier signal ratio (unitless).
Coefficient of repeatability of RBC/barrier signal ratio (unitless).
Echo time to separate RBC and barrier signals by 90 degrees (ms).
Population-wide RBC/barrier signal ratio (unitless).
Secondary Outcome Measures
Full Information
NCT ID
NCT04855305
First Posted
April 19, 2021
Last Updated
April 10, 2023
Sponsor
Bastiaan Driehuys
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital Medical Center, Cincinnati, University of Cincinnati, University of Iowa
1. Study Identification
Unique Protocol Identification Number
NCT04855305
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bastiaan Driehuys
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital Medical Center, Cincinnati, University of Cincinnati, University of Iowa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Interstitial Lung Disease
Arm Type
Active Comparator
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 129Xe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thoracic cavity volume measured in liters.
Time Frame
4 years
Title
RBC/barrier signal ratio (unitless).
Time Frame
4 years
Title
Coefficient of repeatability of RBC/barrier signal ratio (unitless).
Time Frame
4 years
Title
Echo time to separate RBC and barrier signals by 90 degrees (ms).
Time Frame
4 years
Title
Population-wide RBC/barrier signal ratio (unitless).
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bastiaan Driehuys, PhD
Phone
919-684-7786
Email
bastiaan.driehuys@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Mammarappallil, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Fain
Phone
319-356-4832
Email
Sean-fain@uiowa.edu
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Korzekwinski
Phone
919-681-7362
Email
jennifer.korzekwinski@duke.edu
First Name & Middle Initial & Last Name & Degree
Cody Blanton
Phone
919-668-7575
Email
cody.blanton@duke.edu
First Name & Middle Initial & Last Name & Degree
Joseph Mammarappallil, MD
First Name & Middle Initial & Last Name & Degree
Bastiaan Driehuys, PhD
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nishant Gupta
Phone
513-558-4831
Email
guptans@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Nishant Gupta
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zackary Cleveland
Phone
513-803-7186
Email
zackary.cleveland@cchmc.org
First Name & Middle Initial & Last Name & Degree
Zackary Cleveland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.
IPD Sharing Time Frame
A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI. In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.
IPD Sharing Access Criteria
We are committed to making de-identified datasets and image analysis available to to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.
Learn more about this trial
Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
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