Recruiting
Phase 1
Phase 2

Hyperpolarized 129Xe

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT02316379

Conditions

Respiratory Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized 129 Xenon

MRI

Study Details

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 adults for the purposes of obtaining optimal images through MRI.

Conditions

Respiratory Disorders

Study ID

NCT02316379

Start date

Feb, 2015

Status verified date

Apr, 2024

Completion date

Aug 24, 2031

Anticipated

Primary completion date

Aug 24, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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

MRI

Primary outcome measure

  • Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Carrie Stevens, BS

513-636-9973Carrie.Stevens@cchmc.org

Kelly Thornton, BS

513-636-0604Kelly.Thornton@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jason C Woods, Ph.D

513-803-4463jason.woods@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 10, 2025

Last verified

Apr, 2024

Keywords

  • Respiratory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-09-10.