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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02272049
Other study ID # 2014-5279
Secondary ID IND 123577
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2014
Est. completion date August 2027

Study information

Verified date April 2024
Source Children's Hospital Medical Center, Cincinnati
Contact Carrie Stevens, BS
Phone 513-636-9973
Email Carrie.Stevens@cchmc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 2027
Est. primary completion date August 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria: - Ages 6 and up - Participant must be able to hold 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


Intervention

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

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
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