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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2029-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hyperpolarized 129 Xenon

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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HP 129 Xe

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes