Healthy Volunteers - Male and Female
Conditions
Keywords
129 Xe MRI
Brief summary
Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis.
Detailed description
Briefly, during a one hour visit, subjects will provide written informed consent and then undergo: 1. brief medical history and vital signs, 2. full pulmonary function tests, 3. proton MRI, 4. spin-density, diffusion weighted, and/or dissolved phase 129-Xe MRI, Full pulmonary function tests including spirometry and FeNO test according to American Thoracic Society (ATS) guidelines. Subjects will be placed in the 3T Magnetic Resonance (MR) scanner with one 129-Xe chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient radiofrequency (RF) coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.
Interventions
DEVICEHyperpolarized Xenon MRI
Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
Sponsors
Alexei Ouriadov
St. Joseph's Health Care London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Device: Hyperpolarized Xenon MRI
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature. * Provision of written, informed consent prior to any study specific procedures. * Males and females aged 18 to 85 years. * Participant must be able to perform a breath-hold for 16s. * Participant has a BMI between 18 and 40 * Participant must be able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater) * Participants are judged to be in stable health on the basis of medical history
Exclusion criteria
* Patient has an MR incompatible implanted mechanically, electrically, or magnetically activated 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) (at the discretion of the MRI Technologist). * In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI or CT, such as severe claustrophobia. * Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit. * Participant is unable to perform spirometry maneuvers. * Participant is unable to perform MRI and CT breath-hold maneuvers. * Participant has a history of chronic or acute respiratory disease * FEV1 \<70% * Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100) * Participant has a daytime room air oxygen saturation ≤ 92% ± 2% while supine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal-to-noise ratio (SNR) | 5 years | A quantitative measure of image quality that compares the level of the desired signal to the background noise in an MRI image. |
| Contrast-to-noise ratio (CNR) | 5 years | A measure of how well different tissues or structures can be distinguished from each other in an image relative to background noise. |
| Image spatial resolution | 5 years | The primary endpoints are to assess the necessary imaging sequences, reconstruction algorithms, and hardware to acquire high spatial resolution lung images from MRI. Image spatial resolution (mm) is the ability of the imaging system to distinguish small structures, expressed as the smallest detectable detail in millimeters. |
| Scan duration (minutes) | 5 years | The total time required to complete the imaging acquisition for the protocol, measured in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilation Defect Percent (VDP) of the lung | 5 years | VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity. |
Countries
Canada
Contacts
CONTACTHana Serajeddini, MD, FRCPC
CONTACTTommy Li, Msc
Outcome results
None listed