Imaging the lungs and brain using hyperpolarized xenon gas in healthy adults
DEVELOPMENT OF HYPERPOLARIZED XENON-129 LUNG AND/OR BRAIN MAGNETIC RESONANCE IMAGING HARDWARE AND SOFTWARE: HEALTHY ADULT VOLUNTEER PILOT STUDY
This study is testing if using a special gas during MRI scans can create clearer images of the lungs and brain in healthy adults compared to regular MRI methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02195206 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the image quality of lung and brain MRI in healthy adult volunteers using hyperpolarized xenon-129 gas. Conducted at the Hospital for Sick Children in Toronto, the study will involve 90 participants aged 18 to 75 who will undergo MRI scans at 3Tesla with a prototype chest coil and pulse sequence after inhaling the gas. The goal is to determine if xenon MRI can produce images of equal or better quality compared to traditional proton MRI, without the use of ionizing radiation. The study will assess both the structural and functional aspects of the lungs and brain through this innovative imaging technique.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 75 with minimal smoking history and stable health.
Not a fit: Patients with chronic or acute respiratory diseases or cardiovascular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging method could provide a safer and more effective way to visualize lung and brain structures without exposure to ionizing radiation.
How similar studies have performed: While hyperpolarized gas MRI is a relatively new technique, preliminary studies have shown promising results in imaging lung function and structure.
Eligibility criteria
Show full inclusion / exclusion 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)
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
- Email: giles.santyr@sickkids.ca
- Phone: 416-813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.