Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT02740868
• Date of registration: 19/08/2015
• Prospective Registration: No
• Primary sponsor: The Hospital for Sick Children
• Public title: Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease
• Scientific title: Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease
• Date of first enrolment: August 2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02740868
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Giles Santyr, PhD

• Name: Giles Santyr, PhD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion 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 16s.

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).

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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. 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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Age minimum: 8 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Cystic Fibrosis

Intervention(s)

Device: Magnetic Resonance Imaging

Drug: Xenon-129

Device: Lung Clearance Index

Primary Outcome(s)

Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement [Time Frame: 1 year]

Secondary ID(s)

1000048243

Source(s) of Monetary Support

Please refer to primary and secondary sponsors