Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Pulmonary Hypertension, Pulmonary Infection, Other Lung Disease
Conditions
Keywords
Hyperpolarized 129Xe MRI
Brief summary
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.
Detailed description
This is an unblinded, open-label study with \ 160 subjects with diagnosed pulmonary disease and \ 100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (\ 300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.
Interventions
During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.
Sponsors
Mario Castro, MD, MPH
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
Healthy Volunteers: * Subject has no diagnosed pulmonary conditions * Ability to read and understand English or Spanish Subjects with Lung Disease: * Subject has a diagnosis of pulmonary dysfunction made by a physician * No acute worsening of pulmonary function in the past 30 days * Ability to read and understand English or Spanish
Exclusion criteria
* MRI is contraindicated based on responses to MRI screening questionnaire * Subject is pregnant or lactating * Subject does not fit into 129Xe vest coil used for MRI * Subject cannot hold his/her breath for 15-16 seconds * Subject deemed unlikely to be able to comply with instructions during imaging * Oxygen saturation \<88% on room air or with supplemental oxygen * Cognitive deficits that preclude ability to provide consent * Institutionalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC/Barrier Ratio | Day 1 | Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADC | Day 1 | Apparent Diffusion Coefficient of Xenon Gas in the lungs |
| Ventilation Defect Percentage | Day 1 | Percentage of the Lungs with ventilation signal below a threshold level |
Countries
United States
Contacts
CONTACTCristal Monge
PRINCIPAL_INVESTIGATORPeter Niedbalski, PHD
University of Kansas Medical Center
Outcome results
None listed