Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2031-08-24

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 adults for the purposes of obtaining optimal images through MRI.

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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 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 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 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.

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

MRI

Intervention Type DEVICE

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

MRI

Intervention Type DEVICE

Other Intervention Names

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HP 129 Xe

Eligibility Criteria

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Inclusion Criteria

* Adults ages 18 years and older
* Participant must be able to hold their 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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes