Clinical trial NCT04185870: Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum
Official title: Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pectus Excavatum
Funnel Chest
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive standard photographs and a 3D scan
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Standard photography based pectus excavatum depth
timeFrame: 2 months
measure: 3D scan based pectus excavatum depth
timeFrame: 2 months
measure: Absolute agreement between the 3D scan and photography based pectus excavatum depth.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
state: Limburg
Study officials:
References:
citation: 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.