Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities

Chest Wall Disorder Clinical Trial

Official title:

Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279886
• Other study ID #: 2020-6130
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: April 20, 2020

Study information

• Verified date: February 2020
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. The range of three-dimensional scanning systems is broad with even varying systems being used within hospitals. Most of these scanning systems have been validated for accuracy and reproducibility, no comparison between these systems is known. In addition, severity measures of pectus excavatum, as well as other research outcomes, surgical planning techniques, and analysis methods are based on a single imaging system. It is subsequently essential to determine whether different imaging systems can be used interchangeably regarding accuracy and reproducibility.

The aim of this study was to assess the reproducibility and accuracy between three commonly used three-dimensional scanning systems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy volunteers only

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Chest Wall Disorder

Intervention

Other:
• Three-dimensional scans
All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Centre	Heerlen	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility	Mean difference between subsequent scans utilizing the same three-dimensional scanning system	1 month
Primary	Accuracy	Mean difference between scans, acquired by different three-dimensional scanning systems	1 month