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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279886
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Zuyderland Medisch Centrum

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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)
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 : February 20, 2020
Actual Primary Completion Date : March 20, 2020
Actual Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Reproducibility [ Time Frame: 1 month ]
    Mean difference between subsequent scans utilizing the same three-dimensional scanning system

  2. Accuracy [ Time Frame: 1 month ]
    Mean difference between scans, acquired by different three-dimensional scanning systems



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers only

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279886


Locations
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Netherlands
Zuyderland Medical Centre
Heerlen, Limburg, Netherlands, 6419PC
Sponsors and Collaborators
Zuyderland Medisch Centrum
Radboud University
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Responsible Party: Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT04279886    
Other Study ID Numbers: 2020-6130
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No