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¹²⁹Xe(XENON) MRI Program

ConditionHealthy Volunteers - Male and Female
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAlexei Ouriadov

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Hyperpolarized Xenon MRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years
2

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.

Time frame
5 years
3

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.

Time frame
5 years
4

Scan duration (minutes)

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

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexei Ouriadov

Lead sponsor

Western University

Sponsor institution

St. Joseph's Health Care London

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: