Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
ConditionInterstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBastiaan Driehuys
About this trial
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subject has no diagnosed pulmonary conditions
Subject has not smoked in the previous 5 years.
Smoking history, if any, is less than or equal to 5 pack-years.
Subject has a diagnosis of pulmonary dysfunction made by a physician
Disqualifiers
Subject is less than 18 years old
MRI is contraindicated based on responses to MRI screening questionaire
Subject is pregnant or lactating
Respiratory illness of a bacterial or viral etiology within 30 days of MRI
Trial design
Design model
Single group
Treatments tested in this trial
Hyperpolarized 129Xenon Gas
DrugHyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The purpose of this trial is to examine the ability of HP 129Xe imaging to characterize the lung in healthy and diseased states. The safety endpoint for each subject is to record any adverse events as a measure of safety and tolerability. The technical endpoint for each subject is the acquisition of technically adequate HP 129Xe MR images.
Time frame
Day 2Sponsors and contacts
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Bastiaan Driehuys
Lead sponsor
Duke University
Sponsor institution
Source ClinicalTrials.gov