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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT04885387
Collaborator
(none)
11
1
2
14
0.8

Study Details

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, .

Condition or Disease Intervention/Treatment Phase
  • Device: chest CT
  • Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Standard protocol using chest CT

Device: chest CT
chest CT pectus deformities diagnostic

Experimental: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner [At 12 month]

  2. To compare the Haller Index measured with CT and the HI measured with MRI [At 12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de chirurgie infantile Limoges France

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT04885387
Other Study ID Numbers:
  • Ballouhey Xray
First Posted:
May 13, 2021
Last Update Posted:
May 13, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2021