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Three-dimensional Optical Surface Imaging as a Diagnostic Tool in Pectus Excavatum

NCT03926078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-07-02

No results posted yet for this study

Summary

Pectus excavatum (PE) is the most common anterior chest wall deformity. Currently, a chest radiography (CR) or Computed Tomography (CT) scan is acquired to determine and objectify pectus severity using the Haller Index. Alongside other determinants, the Haller Index value is used in the proces of clinical decision making and determine surgical candidacy. However, cross-sectional imaging based calculation of the Haller Index implies exposure to ionizing radiation that should be limited at all times to diminish the cumulative long-term risks of malignancy. Especially in pectus patients that often concerns children.

Three-dimensional (3D) optical surface imaging offers a non-invasive, radiation-free alternative that may be used to obtain thoracic measures and determine pectus severity. However, for 3D images/scans to be used as a diagnostic tool in the proces of clinical decision making and determine surgical candidacy, its diagnostic accuracy should be evaluated. This will be investigated utilizing a pilot study design as no prior accuracy studies are available.

Conditions

  • Pectus Excavatum

Interventions

OTHER

3D optical surface image

3D optical surface images will be acquired and used to calculate the EHI

RADIATION

Chest radiography

Chest radiographies will be acquired and used to calculated the HI and EHI

RADIATION

CT scan

CT scans will be acquired and used to calculate the HI and EHI

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2021-02-28
Completion
2021-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03926078 on ClinicalTrials.gov