X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
1 other identifier
interventional
11
1 country
1
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, .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 9, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedMay 13, 2021
March 1, 2021
11 months
May 9, 2021
May 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Standard protocol using chest CT
OTHERMagnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
EXPERIMENTALInterventions
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic
Eligibility Criteria
You may qualify if:
- children (\< 18 years of age)
- with a pectus deformity
- recent (within the past month) chest CT, cardiothoracic MRI, and 3D scanning data were available.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de chirurgie infantile
Limoges, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2021
First Posted
May 13, 2021
Study Start
April 1, 2019
Primary Completion
March 1, 2020
Study Completion
June 1, 2020
Last Updated
May 13, 2021
Record last verified: 2021-03