Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperpolarized 129 Xenon.
- Who it may be relevant to
- Registry conditions: Respiratory Disorders. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Hyperpolarized 129 Xe MR Lung Imaging in Children and Adults
Overview
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 children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.
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 (less for children) 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 phone calls will be done one day and 30 days from the MRI date.
Interventions
- Drug Hyperpolarized 129 Xenon
During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
Primary outcome measures
- Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Ages 6 and up
- Participant must be able to hold 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT02272049 · 2014-5279 · IND 123577