Clinical Trials Directory

Trials / Completed

CompletedNCT04885387

X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
University Hospital, Limoges · Academic / Other
Sex
All
Age
17 Years
Healthy volunteers
Not accepted

Summary

Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum. In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment . The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI. The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .

Conditions

Interventions

TypeNameDescription
DEVICEchest CTchest CT pectus deformities diagnostic
DEVICEMagnetic Resonance Imaging and a low-cost portable three-dimensional scanning deviceMagnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic

Timeline

Start date
2019-04-01
Primary completion
2020-03-01
Completion
2020-06-01
First posted
2021-05-13
Last updated
2021-05-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04885387. Inclusion in this directory is not an endorsement.