Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBastiaan Driehuys
About this trial
This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis. Researchers will assess whether MRI measurements correlate with clinical measures of lung and vascular function.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years at enrollment.
Participant is willing and able to provide written informed consent.
Able (in the Investigator's opinion) and willing to comply with all study requirements.
Healthy volunteers: aged 18-30 years; no known cardiopulmonary disease; has not smoked tobacco products in the previous 5 years; smoking history, if any, is less than or equal to 5 pack-years; no history of using other inhaled products more than 1 time per week for > 1 year OR
Disqualifiers
Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the participants to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
Inability to hold breath for 10-15 seconds for required imaging or for completion of DLCO measurements.
Active pulmonary infection or lung cancer.
Recent respiratory infection or pulmonary disease exacerbation within 4 weeks of screening.
Trial design
Design model
Single group
Treatments tested in this trial
Hyperpolarized 129 Xenon Gas
DrugHyperpolarized xenon gas is inhaled during MRI to evaluate lung ventilation and gas exchange.
Treatment groups
51 Participants
are divided into 1 treatment groupGroup A: Hyperpolarized Xenon MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy for Detection of Pulmonary Hypertension (sensitivity)
Sensitivity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
Time frame
Single study visit, Day 12
Diagnostic Accuracy for Detection of Pulmonary Hypertension (specificity)
Specificity of pre-specified 129Xe MRI biomarkers for identifying pre-capillary pulmonary hypertension in participants with systemic sclerosis, using right-heart catheterization as the reference standard.
Time frame
Single study visit, Day 1Secondary outcomes
1
RBC Oscillation Imaging Amplitude Defect Percentage
Percentage of lung volume exhibiting abnormal regional RBC oscillation amplitude as measured by hyperpolarized 129Xe MRI.
Time frame
Single study visit, Day 12
Whole-Lung RBC Chemical Shift
Mean frequency difference between the center of the RBC resonance and the alveolar gas resonance.
Time frame
Single study visit, Day 1Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bastiaan Driehuys
Lead sponsor
Duke University
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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