Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperpolarized Xe129.
- Who it may be relevant to
- Registry conditions: Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis. Basic parameters: from 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Hyperpolarized Xe129
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.
Primary outcome measures
- RBC/Barrier Ratio [Time frame: Day 1]
Secondary outcome measures (2)
- ADC [Time frame: Day 1]
- Ventilation Defect Percentage [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT04624490 · STUDY00146119