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MRI Imaging for Asthma

N/A

Recruiting

Led By Grace E Parraga, PhD

Research Sponsored by Dr. Grace Parraga

Eligibility Criteria Checklist

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

Must have

Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)

Subjects male and female aged 18-60 with a clinical diagnosis of asthma

Must not have

Patient is unable to perform spirometry or plethysmography maneuvers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use 129Xenon and/or 3He image acquisition and analysis methods to study the relationship between lung structure and function in 120 asthma patients.

Who is the study for?

This trial is for stable, non-smoking adults aged 18-60 with asthma. Participants must understand the study and consent to it, have a history of less than 1 pack/year of smoking, and be able to perform consistent lung function tests with FEV1 over 60% predicted.

What is being tested?

The trial is using Hyperpolarized Noble Gas MRI technology on 200 volunteers with asthma to explore how their lung structure relates to lung function. It involves imaging lungs using two types of gases: Xenon (129Xenon) and Helium (3He).

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from holding breath during scans or mild dizziness from inhaling noble gases used for MRI imaging.

Eligibility Criteria

Inclusion Criteria

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

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I can perform consistent lung function tests.

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I am between 18 and 60 years old and have been diagnosed with asthma.

Exclusion Criteria

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

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I cannot perform certain lung function tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI

Secondary study objectives

Additional Pulmonary Function measurements

Dyspnea Scale

Forced Expiratory Volume (FEV1) measured by spirometry

+1 more

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: Asthma PatientsExperimental Treatment1 Intervention

All enrolled asthma patients will undergo hyperpolarized noble gas MRI with Helium-3 and/or Xenon-129, Pulmonary Function Tests, Quality of Life Questionnaires, dyspnea scales in two visits over three years.

0 / 3Eligibility criteria met