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

Pectus Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885387
• Other study ID #: Ballouhey Xray
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Congenital Abnormalities
• Pectus Deformity

Intervention

Device:
• chest CT
chest CT pectus deformities diagnostic
• Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic

Locations

Country	Name	City	State
France	Service de chirurgie infantile	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner		At 12 month
Secondary	To compare the Haller Index measured with CT and the HI measured with MRI		At 12 month