Back to resultsX-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
Primary Purpose
Pectus Deformity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
chest CT
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
Sponsored by
About this trial
This is an interventional diagnostic trial for Pectus Deformity
Eligibility Criteria
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:
-
Sites / Locations
- Service de chirurgie infantile
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard protocol using chest CT
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner
To compare the Haller Index measured with CT and the HI measured with MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04885387
Brief Title
X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
Official Title
X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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, .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Deformity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard protocol using chest CT
Arm Type
Other
Arm Title
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
chest CT
Intervention Description
chest CT pectus deformities diagnostic
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
Intervention Description
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner
Time Frame
At 12 month
Title
To compare the Haller Index measured with CT and the HI measured with MRI
Time Frame
At 12 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Service de chirurgie infantile
City
Limoges
Country
France
12. IPD Sharing Statement
Learn more about this trial
X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
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