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

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Respiratory Disorders

Treatments: Device: MRI; Drug: Hyperpolarized 129 Xenon

Study type: Interventional

Funder types: Other

Identifiers

NCT02316379

IND 123577 (Other Identifier)

2014-7643

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Hyperpolarized 129 Xenon

Experimental group

Description:

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.

Treatment:

Drug: Hyperpolarized 129 Xenon

Device: MRI