Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
HpXeMRCal
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 12, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 24, 2031
September 10, 2025
April 1, 2024
15.6 years
December 10, 2014
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 1
Study Arms (1)
Hyperpolarized 129 Xenon
EXPERIMENTALAdministration 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.
Interventions
During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
Eligibility Criteria
You may qualify if:
- Adults ages 18 years and older
- Participant must be able to hold their breath for up to 16 seconds
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason C Woods, Ph.D.
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2014
First Posted
December 12, 2014
Study Start
February 1, 2015
Primary Completion (Estimated)
August 24, 2030
Study Completion (Estimated)
August 24, 2031
Last Updated
September 10, 2025
Record last verified: 2024-04