NCT02740868 Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease
| NCT ID | NCT02740868 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Hospital for Sick Children |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2015-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2015-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.
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). \-
Contact & Investigator
Giles Santyr, PhD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT02740868 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02740868 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02740868 currently recruiting?
Yes, NCT02740868 is actively recruiting participants. Contact the research team at giles.santyr@sickkids.ca for enrollment information.
Where is the NCT02740868 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT02740868 clinical trial?
NCT02740868 is sponsored by The Hospital for Sick Children. The principal investigator is Giles Santyr, PhD at The Hospital for Sick Children. The trial plans to enroll 30 participants.