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Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

Use of Hyperpolarized 129 Xe MR Lung Imaging in Children and Adults

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02272049
Acronym
HPXeMR
Enrollment
300
Registered
2014-10-22
Start date
2014-12-01
Completion date
2029-08-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disorders

Keywords

Respiratory

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.

Interventions

During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRIDay 1quantify 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

Countries

United States

Contacts

CONTACTCarrie Stevens, BS
Carrie.Stevens@cchmc.org513-636-9973
CONTACTKelly Thornton, BS
Kelly.Thornton@cchmc.org513-636-0604
PRINCIPAL_INVESTIGATORJason C. Woods, PhD

Children's Hospital Medical Center, Cincinnati

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026