A Phase 1/2 interventional study of Hyperpolarized 129 Xenon in HSCT, Respiratory and Gas Exchange Impairment, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1/2, Interventional, and Diagnostic
This will be an un-blinded, open-label study of children and adults, including those who are being evaluated for or who have undergone HSCT, those with existing respiratory conditions and/or diagnosed gas-exchange impairment, and healthy control volunteers. The participants will be male or female between 3-17 years old (children) and adults age 18 and older.
The study objective is to:
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:
Hyperpolarized xenon gas will be administered in doses of up to 1/6TLC (based on either ATS calculations that utilize gender and height to determine the dose or plethysmography data) for participants under 18 years old and 1000 milliliters for adults per our previous research experience followed by a breath hold of up to 16 seconds
Drug: Hyperpolarized 129 Xenon
Hyperpolarized xenon gas will be administered in doses of up to 1/6TLC (based on either ATS calculations that utilize gender and height to determine the dose or plethysmography data) for participants under 18 years old and 1000 milliliters for adults per our previous research experience followed by a breath hold of up to 16 seconds
Xe Gas-Exchange MRI
Images reflecting dissolved-phase xenon distribution in pulmonary tissues and blood obtained by xenon MRI
Time frame: Through study completion, an average of 5 years
Establish Aquisition Strategies for Xenon Ventilation Imaging
Ventilation defect percentage (i.e., hypoventilated lung volume) will be analyzed following the xenon MRI
Time frame: Through study completion, an average of 5 years
Percentage difference between Xe MRIs repeated within the same-day
Quantitative outcomes from Xe MRI scans, like the ventilation defect percentage (i.e., hypoventilated lung volume), from within the same participant will be compared using paired statistical tests to assess the same-day repeatability.
Time frame: Through study completion, an average of 5 years
Correlation between FEV1 and FEV1/FVC from spirometry with ventilation-defect percentage from Xe MRI.
The correlation between FEV1 and FEV1/FVC measured in liters and/or percent predicted from reference equations and the VDP (ventilation defect percentage) from Xe MRI will be determined.
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
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