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

NCT04279886 | Completed

• 1 other identifier: 2020-6130
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chest Wall Disorder

Outcome Measures

Primary Outcomes (2)

• Reproducibility

  Mean difference between subsequent scans utilizing the same three-dimensional scanning system

  1 month

• Accuracy

  Mean difference between scans, acquired by different three-dimensional scanning systems

  1 month

Study Arms (1)

Three-dimensional scan arm

OTHER

Other: Three-dimensional scans

Interventions

Three-dimensional scans OTHER

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

Three-dimensional scan arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers only

You may not qualify if:

• none

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: February 21, 2020
• Study Start: February 20, 2020
• Primary Completion: March 20, 2020
• Study Completion: April 20, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-02

Locations

NL (1)