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

Not Applicable

Completed

• Conditions: Pectus Deformity
• Interventions: Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device; Device: chest CT

• Registration Number: NCT04885387
• Lead Sponsor: University Hospital, Limoges

Brief 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, .

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-06-01
• Status Verified: 2021-03
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Last Update Submitted: 2021-05-09
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device	Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device	-
Standard protocol using chest CT	chest CT	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To compare the Haller Index measured with CT and the HI measured with MRI	At 12 month
To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner	At 12 month

Trial Locations

Locations (1)

Service de chirurgie infantile; 🇫🇷 Limoges, France