Assessing Pulmonary Changes in HSCT
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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:
* To optimize the acquisition of images reflecting the "dissolved-phase" Xe distribution in the pulmonary tissues and blood (Xe gas-exchange MRI). * To develop and test Xe MRI acquisition strategies that separately image alveolar airspace distribution (ventilation), as well as Xe dissolved in pulmonary tissues versus red blood cells (RBCs). * To acquire images of Xe ventilation and dissolved-phase Xe regional distribution in the enrolled participants. * To understand the same-day variability of Xe MRI techniques. * To determine the relationship between Xe MRI and clinical measures such as pulmonary-function-test (PFT) parameters or other biological biomarkers. * To develop and optimize strategies for Xe MRI in young children including those who are unable to follow the inhalation and breath-hold instructions typical of the Xe MRI procedure.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 3 years and older
Disqualifiers
Pregnancy or positive pregnancy test
Baseline oximetry at MRI visit of less than 90% on room air or less than 90% on a previously prescribed dosage of oxygen delivered by nasal cannula. In some cases of cardiorespiratory disease, if the participant is referred to this research study by their treating physician and considered stable for imaging, the cardiorespiratory criteria will be 5% of their clinical baseline. This should be documented in the research record upon referral of a participant that meets this scenario.
Any condition in the opinion of the investigator that would make the participant unable to tolerate the MRI procedure (e.g., neurocognitive delay, behavioral issues).
Standard MRI exclusions (e.g., metal, incompatible implants).
Trial design
Design model
Single group
Treatments tested in this trial
Hyperpolarized 129 Xenon
DrugHyperpolarized 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
Treatment groups
550 Participants
are divided into 1 treatment groupGroup A: Hyperpolarized 129 XenonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 yearsSponsors and contacts
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Source ClinicalTrials.gov