Use of Hyperpolarized 129 Xe MR Lung Imaging in Children and Adults
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Hyperpolarized 129 Xenon
Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI (less for children) to optimize acquisition of images for children and adults vs. proton MR imaging
Intervention: Hyperpolarized 129 Xenon (Drug)
Outcomes
Primary Outcomes
Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
Time Frame: Day 1
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 Outcomes
No secondary outcomes reported