A Phase 1/2 interventional study of Hyperpolarized 129 Xenon in HSCT and Lung Transplant Recipient, sponsored by Children's Hospital Medical Center, Cincinnati. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1/2, Interventional, and Diagnostic
The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Specifically, three forms of Xe MRI techniques will be our focus: (1) imaging of the Xe ventilation distribution (which is the current FDA-approved indication for Xe MRI); (2) imaging the alveolar microstructure via the Xe apparent diffusion coefficient (ADC); and (3) detecting via spectroscopy and imaging Xe gas dissolved in the pulmonary blood and tissues upon inhalation.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
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Exclusion Criteria:
This research study will happen immediately following the clinical MRI exam with additional research Xe doses administered after the clinical Xe MRI procedure. Xe gas will be administered to the participant in the same manner as the clinical Xe MRI scan. Research scans without Xe gas may be acquired as well.
Drug: Hyperpolarized 129 Xenon
The total dosing volume will be consistent with CCHMC Department of Radiology clinical standards or up to 1/6th of a participant's total lung capacity (calculated or predicted from ATS guidelines or from participant's plethysmography data if available within 6 months of MRI scan) for participants under 18 years old and 1000 milliliters for adults. No more than a total of five Xe gas doses, combined clinical and research doses, will be administered during the scanning session.
Xenon gas Defect Distribution Index (DDI)
The signal intensity of Xe gas in a voxel (in arbitrary units) as compared to neighboring voxels, with a higher DDI indicating more clustered and focal Xe defects.
Time frame: Through study completion, an average of 5 years
Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace.
Measurement of the Xe apparent-diffusion coefficient (ADC), in units of cm\^2/s, with a larger value indicating more airspace dilation.
Time frame: Through study completion, an average of 5 years
Xenon RBC:Membrane ratio
The ratio of Xe signal intensity (in arbitrary units) within the red-blood cell (RBC) compartment and membrane (interstitial tissue) compartments of pulmonary diffusion measured during dissolved-phase Xe MRI.
Time frame: Through study completion, an average of 5 years
Xe gas time constant
The rate at which Xe gas signal intensity changes during dynamic images, in arbitrary units/second.
Time frame: Through study completion, an average of 5 years
Length in time of Xe MRI acquisition
Measurement of time in seconds for the duration of the Xe MRI acquisition.
Time frame: Through study completion, an average of 5 years
Plan to share: No
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Studies of the drug tested here: Xenon XE-129
Children's Hospital Medical Center, Cincinnati →