Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT03539770
Adolescent Idiopathic Scoliosis (AIS) is a curvature of the spine that occurs in 1-2% of otherwise healthy children, and requires corrective surgery, posterior spinal fusion (PSF) in ~10% of cases. Some studies suggest that pulmonary function is reduced in AIS and that PSF improves pulmonary function. The lung is composed of a large number of branching airways that terminate in gas exchanging units called alveoli, and the number and structure of these alveoli are partially dependent upon lung volume and the forces to which they are exposed--two factors predicted to be altered in AIS. This study uses MRI imaging of inhaled helium to quantify alveolar structure in children with and without AIS before and one-year after PSF. The goals of the study are to determine if alveolar architecture or number are altered in AIS and whether PSF impacts these same measures.
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Notify Me8 year–21 year
All sexes
Observational
Cincinnati, Ohio, 45229, United States
After obtaining informed consent, subjects are trained in a breath holding technique that permits obtaining reproducible proton and hyperpolarized helium (HHE) lung images. 3-Helium is obtained from a vendor and hyperpolarized using an optical spin transfer device (FDA Investigational New Drug (IND) 122,670) and administered through a valved inhalation device while in the MRI scanner. Images are obtained during an ~15 second inspiratory breath hold. Proton MRI images are similarly obtained during a breath hold with room air using an ultrashort echo time sequence. From these MRI images, lung volumes, alveolar sizes, and estimated alveolar numbers are derived. Subjects are reimaged at 1 year to evaluate changes in these parameters during normal lung growth (controls) or after PSF (AIS subjects).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a. Minor surgeries such as G-tube revisions or dental procedures are permissible.
cystic fibrosis, bronchopulmonary dysplasia, asthma, etc.).
Surgical procedure that involves placement of spinal rods to correct spinal curvature
Time frame: Before posterior spinal fusion and one year after
Calculated mean linear intercept as determined by diffusion measurements in HHe MRI
Time frame: Before posterior spinal fusion and one year after
Measured right and left lung volumes as measured by proton MRI
Time frame: Before posterior spinal fusion and one year after
Estimated number of alveoli in right and left lung as calculated from alveolar size and lung volume measures
Time frame: 1 day
Determine differences in mean linear intercept (MLI) as determined by HHe diffusion measurements in AIS vs control and AIS right vs left lung
Time frame: 1 day
Determine differences in lung volume as determined by proton MRI in AIS vs control and AIS right vs left lung
Time frame: 1 day
Determine differences in estimated alveolar number as calculated using MLI and lung volume measures in AIS vs control and AIS right vs left lung
Children's Hospital Medical Center, Cincinnati
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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