Gas Exchange Impairment, HSCT, Respiratory
Conditions
Brief summary
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.
Interventions
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
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ages 3 years and older
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xe Gas-Exchange MRI | Through study completion, an average of 5 years | Images reflecting dissolved-phase xenon distribution in pulmonary tissues and blood obtained by xenon MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establish Aquisition Strategies for Xenon Ventilation Imaging | Through study completion, an average of 5 years | Ventilation defect percentage (i.e., hypoventilated lung volume) will be analyzed following the xenon MRI |
| Percentage difference between Xe MRIs repeated within the same-day | Through study completion, an average of 5 years | 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. |
| Correlation between FEV1 and FEV1/FVC from spirometry with ventilation-defect percentage from Xe MRI. | Through study completion, an average of 5 years | 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. |
Countries
United States
Contacts
CONTACTAshley Borden, MPH
PRINCIPAL_INVESTIGATORLaura Walkup, PhD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed