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

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ClinicalTrials.gov Identifier: NCT02316379
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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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
Respiratory Disorders 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2015
Estimated Primary Completion Date : August 24, 2023
Estimated Study Completion Date : August 24, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Xenon

Arms and Interventions
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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 Name: HP 129 Xe

Device: MRI


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316379


Contacts
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Contact: Carrie Stevens, BS 513-636-9973 Carrie.Stevens@cchmc.org
Contact: Kelly Thornton, BS 513-636-0604 Kelly.Thornton@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jason C Woods, Ph.D    513-803-4463    jason.woods@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jason C Woods, Ph.D. Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02316379    
Other Study ID Numbers: 2014-7643
IND 123577 ( Other Identifier: FDA )
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Respiratory
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Xenon
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs