Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum

Pectus excavatum is the most common congenital anterior chest wall deformity, known to occur in 1:400 of new-borns. Complaints may be of cosmetic nature or as a consequence of (cardio)pulmonary impairment. Part of the current work-up of pectus excavatum patients in Zuyderland Medical Centre (Heerlen, the Netherlands) is visual documentation of the deformity. Visual documentation is performed utilising a single-reflex camera and consists of 5 standard photographs (acquired from different angles) and two specialised recordings. These specialised recordings encompass a recording to measure the pectus excavatum's depth and a raster stereography recording to create a three-dimensional perspective. However, this form of visual documentation is not efficient, as it is time- and labor-intensive for the photographer and patient.

Recently, another study started that aims to investigate whether three-dimensional (3D) optical surface scans can be used to determine pectus severity, as compared to chest radiographs and computed tomography scans (3DPECTUS study; METCZ20190048; NCT03926078). Building on this study it was determined whether 3D optical surface scans can be used as a tool to document the surface geometry of pectus excavatum. To determine whether the current standard photographs and specialised recordings can be replaced by a 3D scan, both methods are compared. To make this comparison, the pectus excavatum depth was chosen as an objective measure of agreement. If there is good agreement, it is assumed that the standard photos can be replaced by a 3D photo in the current work-up. This will subsequently result in a time saving as well as a reduced burden for the patient while acquisition of 3D scans takes only 10 seconds.

Study Overview

• Status: Completed
• Conditions: Funnel Chest; Pectus Excavatum
• Intervention / Treatment: Diagnostic test: 3D scan; Diagnostic test: Standard photography

• Study Type: Interventional
• Enrollment (Actual): 19
• 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: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All participants of the 3D PECTUS study (METCZ20190048; NCT03926078) that received a 3D scan and standard photographies.

Exclusion Criteria:

• Participants in which the photography based pectus excavatum depth was measured in the transversal plane.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 3D scan and standard photography arm; All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum. In addition, all participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.	Diagnostic test: 3D scan; All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum.; Diagnostic test: Standard photography; All participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard photography based pectus excavatum depth	The pectus excavatum depth is derived from one of the specialized recordings. The depth is obtained by placing a rigid bar with rule over the most excavated part in the transversal plane.	2 months
3D scan based pectus excavatum depth	The pectus excavatum depth is calculated by slicing the 3D scan in the longitudinal direction. The pectus depth is subsequently calculated from the transversal slice with the most severe excavation.	2 months
Absolute agreement between the 3D scan and photography based pectus excavatum depth.	The absolute agreement was assessed by calculation of the intraclass correlation coefficient.	2 months

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum

Publications and helpful links

General Publications

• Daemen JHT, Loonen TGJ, Coorens NA, Maessen JG, Maal TJJ, Hulsewe KWE, Vissers YLJ, de Loos ER. Photographic documentation and severity quantification of pectus excavatum through three-dimensional optical surface imaging. J Vis Commun Med. 2020 Oct;43(4):190-197. doi: 10.1080/17453054.2020.1784711. Epub 2020 Aug 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2019
• Primary Completion (ACTUAL): January 2, 2020
• Study Completion (ACTUAL): January 2, 2020

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: METCZ20190151

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