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, .
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Limoges, France
- Service de chirurgie infantile
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Standard protocol using chest CT
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chest CT pectus deformities diagnostic
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Experimental: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
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Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic
|
What is the study measuring?
Primary Outcome Measures
Outcome 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)
Time Frame: At 12 month
|
At 12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner
Time Frame: At 12 month
|
At 12 month
|
|
To compare the Haller Index measured with CT and the HI measured with MRI
Time Frame: At 12 month
|
At 12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ballouhey Xray
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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