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

Respiratory Disorders Clinical Trial

— HpXeMRCal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02316379
• Other study ID #: 2014-7643
• Secondary ID: IND 123577
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2015
• Est. completion date: August 24, 2026

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
• 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 adults for the purposes of obtaining optimal images through MRI.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 24, 2026
• Est. primary completion date: August 24, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disorders
• Respiratory Tract Diseases

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

Device:
• MRI

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