Clincosm LogoSign in Get a demo

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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT02316379
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
114.7
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyperpolarized 129 Xenon
  • Device: MRI
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Aug 24, 2023
Anticipated Study Completion Date :
Aug 24, 2024

Arms and Interventions

Arm Intervention/Treatment
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
During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
Other Names:
  • HP 129 Xe

    • Device: MRI

    Outcome Measures

    Primary Outcome Measures

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

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Principal Investigator: Jason C Woods, Ph.D., Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02316379
    Other Study ID Numbers:
    • 2014-7643
    • IND 123577
    First Posted:
    Dec 12, 2014
    Last Update Posted:
    Dec 19, 2020
    Last Verified:
    Dec 1, 2020
    Keywords provided by Children's Hospital Medical Center, Cincinnati
    Respiratory
    Additional relevant MeSH terms:
    Respiration Disorders
    Respiratory Tract Diseases
    Xenon

    Study Results

    No Results Posted as of Dec 19, 2020