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129 Xenon MRI in Chronic Lung Disease

ConditionLung Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWestern University, Canada

About this trial

Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect percent (VDP) and pulmonary gas exchange measurements obtained by analysis of hyperpolarized 129-Xe MRI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects male and female aged 18-85 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, and lymphangioleiomyomatosis (LAM)

Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent

Subject must be able to perform a breathhold for 16s.

Subject is judged to be in otherwise stable health on the basis of medical history

Disqualifiers

Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material.

Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine.

Patient is unable to perform spirometry or plethysmography maneuvers

Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.

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

100 Participants
are divided into 1 treatment group
Group A: MRI at baseline and over timeOther 1 intervention

Trial outcomes

Primary 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

Secondary outcomes

1

Apparent Diffusion Coefficients (ADC) of the lung

Diffusion weighted noble gas MRI provides a way to quantify pulmonary microstructure by sensing the movements of inhaled gas atoms. The "apparent" dif fusion coefficient (ADC) during the diffusion time interval can be used to reflect the extent of alveolar restriction of gas atom movements, providing a surrogate measurement of airspace dimensions.

Time frame
5 years
2

Dissolved phase spectroscopy measurements

129-Xe dissolved phase MRI data will be reconstructed using a re-gridding method. The following ratios will be determined by the area-under-the curve obtained from spectroscopy: red-blood-cell to alveolar membrane ratio (RBC:membrane); RBC to gas ratio (RBC:gas); and the membrane to gas ratio (membrane:gas). Spectroscopic signals will be used to reconstruct perfusion and alveolar membrane maps.

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Western University, Canada

Lead sponsor

Source ClinicalTrials.gov
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