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Hyperpolarized Xenon MRI for Respiratory Disorders (HPXeMR Trial)

Phase 1 & 2

Recruiting

Led By Jason C. Woods, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

History of heart defect

Symptoms of respiratory infection within past week (loose or productive cough or wheeze, chest tightness, or sinus infection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand if hyperpolarized gas MRI can be used to assess regional lung function in children and adults with respiratory diseases.

Who is the study for?

This trial is for children and adults aged 6 or older who can hold their breath for up to 16 seconds. It's not suitable for pregnant individuals, those with recent respiratory infections, low oxygen levels without support, metal implants that interfere with MRI, heart defects, uncontrolled asthma, or claustrophobia.

What is being tested?

The study tests the use of Hyperpolarized 129 Xenon gas during an MRI scan to assess lung function in healthy people as well as those with compromised lungs due to various diseases.

What are the potential side effects?

While the document doesn't specify side effects, generally hyperpolarized xenon gas is considered safe but may cause dizziness or a feeling of lightheadedness during inhalation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart defects.

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I have had symptoms of a respiratory infection in the last week.

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I've used my asthma rescue inhaler 2 or more times in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hyperpolarized 129 XenonExperimental Treatment1 Intervention

Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI (less for children) to optimize acquisition of images for children and adults vs. proton MR imaging

0 / 3Eligibility criteria met