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RecruitingNCT02316379HpXeMRCalUpdated Sep 14, 2026

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

A Phase 1/2 interventional study of Hyperpolarized 129 Xenon and MRI in Respiratory Disorders, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1/2, Interventional, and Diagnostic

Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 adults for the purposes of obtaining optimal images through MRI.

Read the 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 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.

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Conditions studied

  • Respiratory Disorders

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Keywords

  • Respiratory
03

In context

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

This study's planned enrollment of 100 is above the median of 69 across 216 interventional studies indexed under Respiration Disorders.

Browse Respiration Disorders studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults ages 18 years and older
  • Participant must be able to hold their breath for up to 16 seconds

Exclusion criteria

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).
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Hyperpolarized 129 Xenon · Device: MRI

Interventions

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

    Also known as: HP 129 Xe

  • DeviceMRI
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What researchers measure

Primary outcomes

  1. Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI

    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

    Time frame: Day 1

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Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02316379
Responsible party
Sponsor
First posted
Dec 12, 2014
Start date
Feb 2015
Primary completion
Dec 24, 2031 (estimated)
Completion
Dec 24, 2032 (estimated)
Last update
Sep 14, 2026

Study contacts

Carrie Stevens, BS
Contact
Carrie.Stevens@cchmc.org
513-636-9973
Kelly Thornton, BS
Contact
Kelly.Thornton@cchmc.org
513-636-0604
Jason C Woods, Ph.D.
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Xenon XE-129

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