Back to resultsHyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Primary Purpose
Asthma, COPD, Interstitial Lung Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Xe129
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring Hyperpolarized 129Xe MRI
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers:
- Subject has no diagnosed pulmonary conditions
- Ability to read and understand English or Spanish
Subjects with Lung Disease:
- Subject has a diagnosis of pulmonary dysfunction made by a physician
- No acute worsening of pulmonary function in the past 30 days
- Ability to read and understand English or Spanish
Exclusion Criteria:
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject is pregnant or lactating
- Subject does not fit into 129Xe vest coil used for MRI
- Subject cannot hold his/her breath for 15-16 seconds
- Subject deemed unlikely to be able to comply with instructions during imaging
- Oxygen saturation <88% on room air or with supplemental oxygen
- Cognitive deficits that preclude ability to provide consent
- Institutionalization
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperpolarized 129Xe
Arm Description
Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.
Outcomes
Primary Outcome Measures
RBC/Barrier Ratio
Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues
Secondary Outcome Measures
ADC
Apparent Diffusion Coefficient of Xenon Gas in the lungs
Ventilation Defect Percentage
Percentage of the Lungs with ventilation signal below a threshold level
Full Information
NCT ID
NCT04624490
First Posted
October 31, 2020
Last Updated
November 12, 2022
Sponsor
Mario Castro, MD, MPH
1. Study Identification
Unique Protocol Identification Number
NCT04624490
Brief Title
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Official Title
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
October 26, 2025 (Anticipated)
Study Completion Date
October 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mario Castro, MD, MPH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.
Detailed Description
This is an unblinded, open-label study with ~160 subjects with diagnosed pulmonary disease and ~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Pulmonary Hypertension, Pulmonary Infection, Other Lung Disease
Keywords
Hyperpolarized 129Xe MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperpolarized 129Xe
Arm Type
Experimental
Arm Description
Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Xe129
Other Intervention Name(s)
HP Xenon
Intervention Description
During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.
Primary Outcome Measure Information:
Title
RBC/Barrier Ratio
Description
Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
ADC
Description
Apparent Diffusion Coefficient of Xenon Gas in the lungs
Time Frame
Day 1
Title
Ventilation Defect Percentage
Description
Percentage of the Lungs with ventilation signal below a threshold level
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers:
Subject has no diagnosed pulmonary conditions
Ability to read and understand English or Spanish
Subjects with Lung Disease:
Subject has a diagnosis of pulmonary dysfunction made by a physician
No acute worsening of pulmonary function in the past 30 days
Ability to read and understand English or Spanish
Exclusion Criteria:
MRI is contraindicated based on responses to MRI screening questionnaire
Subject is pregnant or lactating
Subject does not fit into 129Xe vest coil used for MRI
Subject cannot hold his/her breath for 15-16 seconds
Subject deemed unlikely to be able to comply with instructions during imaging
Oxygen saturation <88% on room air or with supplemental oxygen
Cognitive deficits that preclude ability to provide consent
Institutionalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristal Monge
Phone
913-945-9399
Email
chernandez@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Niedbalski, PHD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J Niedbalski, PhD
Phone
913-588-2271
Email
pniedbalski@kumc.edu
12. IPD Sharing Statement
Learn more about this trial
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
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