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

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.

Study Overview

• Status: Completed
• Conditions: Chest Wall Disorder
• Intervention / Treatment: Other: Three-dimensional scans

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419PC
      • Zuyderland Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers only

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Three-dimensional scan arm	Other: Three-dimensional scans; All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Collaborators: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-6130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No