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

• Sponsor: Zuyderland Medisch Centrum (Other)
• Overall Status: Completed
• CT.gov ID: NCT04279886
• Collaborator: Radboud University Medical Center (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chest Wall Disorder	Other: Three-dimensional scans	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities
• Actual Study Start Date: Feb 20, 2020
• Actual Primary Completion Date: Mar 20, 2020
• Actual Study Completion Date: Apr 20, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Reproducibility [1 month]

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

2. Accuracy [1 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy volunteers only

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zuyderland Medical Centre	Heerlen	Limburg	Netherlands	6419PC

Sponsors and Collaborators

• Zuyderland Medisch Centrum
• Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zuyderland Medisch Centrum
• ClinicalTrials.gov Identifier: NCT04279886
• Other Study ID Numbers: 2020-6130
• First Posted: Feb 21, 2020
• Last Update Posted: Jul 2, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 2, 2020