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Completed

NCT Number: NCT04885387

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

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, .

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Key information

Conditions

Pectus Deformity

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de chirurgie infantile

Limoges, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

chest CT

Device

chest CT pectus deformities diagnostic

Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device

Device

Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic

Primary outcomes

  1. 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)

    Time frame: At 12 month

Secondary outcomes

  1. To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner

    Time frame: At 12 month

  2. To compare the Haller Index measured with CT and the HI measured with MRI

    Time frame: At 12 month

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2021
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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