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

Last updated: April 23, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Hyperpolarized 129 Xenon

Clinical Study ID

NCT02272049
2014-5279
IND 123577
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

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 children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 6 and up
  • Participant must be able to hold breath for up to 16 seconds

Exclusion

Exclusion Criteria:

  • History of heart defect
  • Pregnancy or positive pregnancy test
  • History of uncontrolled asthma defined for this study as requiring use of rescueinhaler ≥ 2 times in past month
  • Symptoms of respiratory infection (loose or productive cough or wheeze), chesttightness, or sinus infection within past week
  • Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on apreviously prescribed dosage of oxygen delivered by nasal cannula
  • Participant is claustrophobic and unable to tolerate the imaging.
  • Standard MRI exclusions (metal, implants)

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Hyperpolarized 129 Xenon
Phase: 1/2
Study Start date:
December 01, 2014
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.