Using Xenon-129 MRI to Study Lung Function in Healthy and Diseased Lungs

Development of Hyperpolarized Xenon-129 and Inert Fluorinated Gas Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease

This study is testing a new type of MRI using a special gas to see if it can help us understand lung function better in people with cystic fibrosis and asthma compared to healthy individuals.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: The Hospital for Sick Children (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT02740868 on ClinicalTrials.gov

What this trial studies

This study evaluates the image quality and reproducibility of Xenon-129 and inert fluorinated gas MRI to assess lung structure and function in individuals with cystic fibrosis and asthma compared to healthy volunteers. The innovative approach utilizes hyperpolarized noble gases to provide high-resolution images of lung airspaces without ionizing radiation, making it particularly suitable for children. Participants will undergo MRI scans after inhaling the hyperpolarized gas, allowing researchers to gather detailed information about lung function and morphology. The study aims to establish the effectiveness of this imaging technique in clinical settings.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 8 years and older with cystic fibrosis or asthma who have a clinical diagnosis and meet specific pulmonary function criteria.

Not a fit: Patients with a smoking history or those unable to perform the required pulmonary function tests may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic imaging techniques for lung diseases, enhancing patient care and treatment outcomes.

How similar studies have performed: While hyperpolarized gas MRI is a relatively new technique, preliminary studies have shown promise in imaging lung function, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Participants male and female aged 8 years old and older.
2. Participants have no smoking history.
3. For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.
4. Participants should have a FEV1%pred value greater than 40%.
5. Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
6. Participant must be able to perform a breath hold for 20s or less.
7. Participant able to perform reproducible pulmonary function tests (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).

For the PEx sub-cohort, admission to the Hospital for Sick Children for a pulmonary exacerbation (based on clinical or pulmonary function assessment). Children who will be admitted and then discharged on home IV antibiotics may also be included in this study.

Exclusion Criteria:

1. Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or cannot read or understand the written material.
2. Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
3. Other than for the PEx sub-cohort, participant has had a cold or respiratory infection in the last four weeks.
4. Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
5. Participant is unable to perform spirometry or plethysmography maneuvers.
6. Participant is pregnant or lactating.
7. In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
8. Participant has an MRI incompatible device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio prosthetic, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).

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Where this trial is running

Toronto, Ontario

• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Giles Santyr, PhD — The Hospital for Sick Children
• Study coordinator: Giles Santyr, PhD

Conditions Cystic Fibrosis; Asthma; Magnetic Resonance Imaging,cystic fibrosis,asthma,healthy