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

Study Overview
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Brief Summary
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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, .

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

Conditions
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Pectus Deformity

Intervention / Treatment
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* Device: chest CT
* Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children (< 18 years of age) with a pectus deformity recent (within the past month) chest CT, cardiothoracic MRI, and 3D scanning data were available. Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard protocol using chest CT<br> | Device: chest CT<br>* chest CT pectus deformities diagnostic<br>|
| Experimental: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device<br> | Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device<br>* Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare a standard protocol using chest CT to a non-irradiant protocol involving a low-cost portable three-dimensional scanner and MRI for all pectus deformities based on the Haller index (HI) |  | At 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner |  | At 12 month | 
| To compare the Haller Index measured with CT and the HI measured with MRI |  | At 12 month |