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

Phase 1

Recruiting

• Conditions: Respiratory Disorders
• Interventions: Drug: Hyperpolarized 129 Xenon; Device: MRI

• Registration Number: NCT02316379
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

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 Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Study Start: 2015-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-08-24
• Study Completion: 2026-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperpolarized 129 Xenon	MRI	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.
Hyperpolarized 129 Xenon	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States