¹²⁹Xe(XENON) MRI Program

HARDWARE AND SOFTWARE DEVELOPMENT FOR PULMONARY MAGNETIC RESONANCE IMAGING USING INHALED INERT HYPERPOLARIZED ¹²⁹XENON GAS

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers - Male and Female
• Intervention / Treatment: Device: Hyperpolarized Xenon MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hana Serajeddini, MD, FRCPC; Phone Number: 66288 (519) 646-6100; Email: hana.serajeddini@lhsc.on.ca
• Study Contact Backup: Name: Tommy Li, Msc; Email: zli3569@uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St Joseph's Healthcare London
      • Contact: Hana Serajeddini, MD, FRCPC; Phone Number: 66288 (519) 646-6100; Email: hana.serajeddini@lhsc.on.ca
      • Contact: Tommy Li; Email: zli3569@uwo.ca
      • Principal Investigator: Alexei Ouriadov, PhD
      • Sub-Investigator: Anurag Bhalla, MD, FRCPC
      • Sub-Investigator: Grace Parraga, PhD
      • Principal Investigator: Hana Serajeddini, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hyperpolarized Xenon MRI; Participants will undergo pulmonary function tests, 129 Xenon MRI at the visit.

Device: Hyperpolarized 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal-to-noise ratio (SNR)	A quantitative measure of image quality that compares the level of the desired signal to the background noise in an MRI image.	5 years
Contrast-to-noise ratio (CNR)	A measure of how well different tissues or structures can be distinguished from each other in an image relative to background noise.	5 years
Image spatial resolution	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.	5 years
Scan duration (minutes)	The total time required to complete the imaging acquisition for the protocol, measured in minutes.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation Defect Percent (VDP) of the lung	VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity.	5 years

Collaborators and Investigators

• Sponsor: Alexei Ouriadov
• Collaborators: St. Joseph's Health Care London

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: 129 Xe MRI
• Other Study ID Numbers: SJHC0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified individual participant data supporting the results will be shared beginning 9 months after publication, available for up to 5 years. Access is open to researchers with approved proposals, subject to a data use agreement. Data will be shared via a secure platform upon approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No