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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04855305
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : April 17, 2024
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
University of Iowa
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Interstitial Lung Diseases Drug: Hyperpolarized 129Xe Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
Actual Study Start Date : November 12, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Patients with Interstitial Lung Disease 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.
Active Comparator: Healthy Volunteers 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.


Outcome Measures
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Primary Outcome Measures :
  1. Thoracic cavity volume measured in liters. [ Time Frame: 4 years ]
  2. RBC/barrier signal ratio (unitless). [ Time Frame: 4 years ]
  3. Coefficient of repeatability of RBC/barrier signal ratio (unitless). [ Time Frame: 4 years ]
  4. Echo time to separate RBC and barrier signals by 90 degrees (ms). [ Time Frame: 4 years ]
  5. Population-wide RBC/barrier signal ratio (unitless). [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855305


Contacts
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Contact: Bastiaan Driehuys, PhD 919-684-7786 bastiaan.driehuys@duke.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Sean Fain    319-356-4832    Sean-fain@uiowa.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Korzekwinski    919-681-7362    jennifer.korzekwinski@duke.edu   
Contact: Cody Blanton    919-668-7575    cody.blanton@duke.edu   
Principal Investigator: Joseph Mammarappallil, MD         
Sub-Investigator: Bastiaan Driehuys, PhD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Nishant Gupta    513-558-4831    guptans@ucmail.uc.edu   
Principal Investigator: Nishant Gupta         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Zackary Cleveland    513-803-7186    zackary.cleveland@cchmc.org   
Principal Investigator: Zackary Cleveland         
Sponsors and Collaborators
Bastiaan Driehuys
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
University of Iowa
Investigators
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Principal Investigator: Joseph Mammarappallil, MD Duke University
More Information
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Responsible Party: Bastiaan Driehuys, Professor of Radiology, Duke University
ClinicalTrials.gov Identifier: NCT04855305    
Other Study ID Numbers: Pro00107570
R01HL126771 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases