¹²⁹Xe(XENON) MRI Program

NCT07533981 | Not Yet Recruiting

• 1 other identifier: SJHC0002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers - Male and Female

Keywords

129 Xe MRI

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Ventilation Defect Percent (VDP) of the lung

  5 years

Study Arms (1)

Hyperpolarized Xenon MRI

EXPERIMENTAL

Participants will undergo pulmonary function tests, 129 Xenon MRI at the visit.

Device: Hyperpolarized Xenon MRI

Interventions

Hyperpolarized Xenon MRI DEVICE

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.

Hyperpolarized Xenon MRI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexei Ouriadov: lead
• St. Joseph's Health Care London: collaborator

Study Sites (1)

St Joseph's Healthcare London

London, Ontario, N6A 4V2, Canada

Location

Central Study Contacts

Hana Serajeddini, MD, FRCPC

CONTACT

(519) 646-6100; hana.serajeddini@lhsc.on.ca

Tommy Li, Msc

CONTACT

zli3569@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, professor, scientist

Model Details: Device: Hyperpolarized Xenon MRI

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): April 30, 2031
• Last Updated: April 16, 2026

Record last verified: 2025-07

Locations

CA (1)