Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration (HpXeMRCal)
Primary Purpose
Respiratory Disorders
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 129 Xenon
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Disorders focused on measuring Respiratory
Eligibility Criteria
Inclusion Criteria:
- Adults ages 18 years and older
- Participant must be able to hold their breath for up to 16 seconds
Exclusion Criteria:
- History of heart defect
- Pregnancy or positive pregnancy test
- History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month.
- Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week.
- Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
- Participant is claustrophobic and unable to tolerate the imaging.
- Standard MRI exclusions (metal, implants).
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperpolarized 129 Xenon
Arm Description
Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI to optimize acquisition of images for adults vs. proton MR imaging. These scans, utilizing volunteers for calibration, may be utilized through this study to optimize the scan details.
Outcomes
Primary Outcome Measures
Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
quantify the measurement agreement between the ventilated volume of healthy lungs predicted via 129 Xe MRI and the ventilated volume of the pleural cavity predicted via proton MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02316379
First Posted
December 10, 2014
Last Updated
February 21, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02316379
Brief Title
Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
Acronym
HpXeMRCal
Official Title
Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 24, 2024 (Anticipated)
Study Completion Date
August 24, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of adults for the purposes of obtaining optimal images through MRI.
Detailed Description
Hyperpolarized 129Xe will be produced, by trained staff, using a polarizer housed at Cincinnati Children's Hospital Medical Center. Individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses for up to four MRI scans. Subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the MRI scans. In addition to 129 Xe MRI, a series of anatomical conventional proton MR images may also be collected. Follow up will be done one day and 30 days from the MRI date.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disorders
Keywords
Respiratory
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperpolarized 129 Xenon
Arm Type
Experimental
Arm Description
Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI to optimize acquisition of images for adults vs. proton MR imaging. These scans, utilizing volunteers for calibration, may be utilized through this study to optimize the scan details.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 129 Xenon
Other Intervention Name(s)
HP 129 Xe
Intervention Description
During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
Description
quantify the measurement agreement between the ventilated volume of healthy lungs predicted via 129 Xe MRI and the ventilated volume of the pleural cavity predicted via proton MRI
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults ages 18 years and older
Participant must be able to hold their breath for up to 16 seconds
Exclusion Criteria:
History of heart defect
Pregnancy or positive pregnancy test
History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month.
Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week.
Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
Participant is claustrophobic and unable to tolerate the imaging.
Standard MRI exclusions (metal, implants).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Stevens, BS
Phone
513-636-9973
Email
Carrie.Stevens@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Thornton, BS
Phone
513-636-0604
Email
Kelly.Thornton@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason C Woods, Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
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
Jason C Woods, Ph.D
Phone
513-803-4463
Email
jason.woods@cchmc.org
12. IPD Sharing Statement
Learn more about this trial
Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
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