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HP 129Xe MRI for Lung Function Assessment (HpXeMRCal Trial)

Phase 1 & 2

Recruiting

Led By Jason C Woods, Ph.D.

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

Participant must be able to hold their breath for up to 16 seconds

Be older than 18 years old

Must not have

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

History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if HP 129Xe gas MRI can be used to assess regional lung function in adults without lung disease.

Who is the study for?

This trial is for adults who can hold their breath for up to 16 seconds. It's not suitable for those with heart defects, uncontrolled asthma, low oxygen levels without support, or recent respiratory infections. Pregnant individuals and those with MRI-incompatible implants are also excluded.

What is being tested?

The study tests the effectiveness of using hyperpolarized Xenon (129Xe) gas during an MRI to assess lung function in healthy adults. The aim is to achieve optimal imaging results that could help understand lung health better.

What are the potential side effects?

While the trial involves inhaling a special gas and undergoing an MRI scan, potential side effects may include discomfort from holding one's breath and temporary dizziness or lightheadedness from the hyperpolarized xenon.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can hold my breath for up to 16 seconds.

Exclusion Criteria

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

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I've had symptoms like a cough, chest tightness, or sinus infection in the last week.

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

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I have a history of heart defects.

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 Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

0 / 4Eligibility criteria met