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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

NCT04885387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-05-13

No results posted yet for this study

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, .

Conditions

  • Pectus Deformity

Interventions

DEVICE

chest CT

chest CT pectus deformities diagnostic

DEVICE

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

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-03-01
Completion
2020-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885387 on ClinicalTrials.gov