Hyperpolarized Xenon-129 Lung and/or Brain Magnetic Resonance Imaging: Healthy Adult Volunteer Pilot Study

Launched by THE HOSPITAL FOR SICK CHILDREN · Jul 18, 2014

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to take pictures of the lungs using a special type of MRI called xenon MRI. Unlike regular MRIs, which use standard hydrogen gas, this technique uses a gas called hyperpolarized xenon-129. The study aims to see if the images produced by xenon MRI are as good as or better than those from traditional MRIs. The trial will take place at the Hospital for Sick Children in Toronto, Canada, and will involve 32 healthy adult volunteers aged 18 to 75.

To be eligible to participate, volunteers should have a history of smoking of no more than one pack per year and be in stable health. They should also be able to hold their breath for 16 seconds and must have a body mass index (BMI) between 18 and 40. Participants will not be able to join if they have certain health issues, such as chronic lung or heart problems, or if they have any metal devices in their body that are not MRI-safe. Those who join the study can expect a non-invasive procedure that does not involve radiation, and they will help researchers understand how this new imaging technique could improve the way we look at lung health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects male and female aged 18-75
• • Subject has a smoking history of ≤ 1 pack year
• • Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
• • Subject must be able to perform a breath hold for 16 seconds
• • Subject has a Body Mass Index (BMI) between 18 and 40
• • Subject is judged to be in stable health on the basis of medical history
• • Subject able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
• Exclusion Criteria:
• • Subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
• • Subject has a history of chronic or acute respiratory disease
• • Subject has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
• • Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine
• • Subject is unable to perform spirometry or plethysmography maneuvers
• • Subject is pregnant or lactating
• • In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
• • Subject 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, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants)