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Hyperpolarized 129Xe MRI for Lung Disease

N/A

Recruiting

Led By Parameswaran Nair, MD, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

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

Must have

No current or previous history of respiratory infection or disease

Subjects male or female aged 18-85 years

Must not have

Age < 18 years or >85 years

Patient is unable to perform spirometry or plethysmography maneuvers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use magnetic resonance imaging to study the lungs of people with and without lung disease, in order to better understand how the lungs work and how to treat them better.

Who is the study for?

This trial is for healthy adults and those with various lung diseases, aged 18-85. Participants must understand English and consent to the study. Exclusions include pregnancy, inability to perform certain lung tests, severe claustrophobia, or having metal implants that affect MRI safety.

What is being tested?

The study explores the use of hyperpolarized xenon-129 (129Xe) MRI in assessing lung structure and function in both healthy individuals and patients with a range of lung conditions. It aims to improve understanding of these diseases and responses to treatments.

What are the potential side effects?

As this trial involves MRI scanning using hyperpolarized xenon gas, side effects may be minimal but can include discomfort from lying still during the scan or feelings of claustrophobia. There are no known significant side effects from inhaling hyperpolarized xenon.

Eligibility Criteria

Inclusion Criteria

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

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I have never had a respiratory infection or disease.

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I am between 18 and 85 years old.

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I am between 18-85 years old and have a diagnosed lung condition.

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I am between 18-85 years old with a diagnosed lung disease.

Exclusion Criteria

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

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I am younger than 18 or older than 85.

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I cannot perform certain lung function tests.

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I am not currently smoking and have never smoked 10 or more packs a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-5 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

Apparent Diffusion Coefficient (ADC)

Ventilation Defect Percent (VDP)

Secondary study objectives

Signal-to-noise ratio (SNR)

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: Patients with and without lung diseaseExperimental Treatment1 Intervention

All enrolled patients will undergo pulmonary function testing, questionnaires, 1H MRI, static ventilation and/or diffusion-weighted hyperpolarized 129Xe MRI and sputum induction at one or more timepoints over five years.

0 / 7Eligibility criteria met