HSCT, Lung Transplant Recipient
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Participant is having a clinically-ordered hyperpolarized Xe gas MRI scan
Exclusion criteria
* Pregnancy or positive pregnancy test * Standard MRI exclusions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xenon gas Defect Distribution Index (DDI) | Through study completion, an average of 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace. | Through study completion, an average of 5 years | Measurement of the Xe apparent-diffusion coefficient (ADC), in units of cm\^2/s, with a larger value indicating more airspace dilation. |
| Xenon RBC:Membrane ratio | Through study completion, an average of 5 years | 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. |
| Xe gas time constant | Through study completion, an average of 5 years | The rate at which Xe gas signal intensity changes during dynamic images, in arbitrary units/second. |
| Length in time of Xe MRI acquisition | Through study completion, an average of 5 years | Measurement of time in seconds for the duration of the Xe MRI acquisition. |
Countries
United States
Outcome results
None listed