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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

U

University of Limoges (UL)

Status

Completed

Conditions

Pectus Deformity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04885387
Ballouhey Xray

Details and patient eligibility

About

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, .

Enrollment

11 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Standard protocol using chest CT
Other group
Treatment:
Device: chest CT
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
Experimental group
Treatment:
Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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