Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07533981

¹²⁹Xe(XENON) MRI Program

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Joseph's Healthcare London

London, Ontario, N6A 4V2, Canada

Location contact

Alexei Ouriadov, PhD

PRINCIPAL_INVESTIGATOR

Anurag Bhalla, MD, FRCPC

SUB_INVESTIGATOR

Grace Parraga, PhD

SUB_INVESTIGATOR

Hana Serajeddini, MD, FRCPC

CONTACT

[email protected]

(519) 646-6100 ext. 66288

Hana Serajeddini, MD, FRCPC

PRINCIPAL_INVESTIGATOR

Tommy Li

CONTACT

[email protected]

About this study

Briefly, during a one hour visit, subjects will provide written informed consent and then undergo:

  • brief medical history and vital signs,
  • full pulmonary function tests,
  • proton MRI,
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Signal-to-noise ratio (SNR)

    Time frame: 5 years

    A quantitative measure of image quality that compares the level of the desired signal to the background noise in an MRI image.

  2. Contrast-to-noise ratio (CNR)

    Time frame: 5 years

    A measure of how well different tissues or structures can be distinguished from each other in an image relative to background noise.

  3. Image spatial resolution

    Time frame: 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.

  4. Scan duration (minutes)

    Time frame: 5 years

    The total time required to complete the imaging acquisition for the protocol, measured in minutes.

Secondary outcomes

  1. Ventilation Defect Percent (VDP) of the lung

    Time frame: 5 years

    VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity.

Study contacts

Contact information is provided by the study sponsor or research team.

Hana Serajeddini, MD, FRCPC

CONTACT

[email protected]

(519) 646-6100 ext. 66288

Tommy Li, Msc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Alexei Ouriadov

Other

Collaborators

  • St. Joseph's Health Care London

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.