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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04885387

Enrollment

Registered

2021-05-13

Start date

2019-04-01

Completion date

2020-06-01

Last updated

2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pectus Deformity

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, .

Interventions

DEVICEchest CT

chest CT pectus deformities diagnostic

DEVICEMagnetic 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026