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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03926078

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 2, 2020

Study Description

Brief 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.

  • Condition or Disease:Pectus Excavatum
  • Intervention/Treatment: Other: 3D optical surface image
    Radiation: Chest radiography
    Radiation: CT scan
  • Phase: N/A
Detailed Description

This single-centre prospective pilot study is conducted to assess the diagnostic accuracy of 3D optical surface imaging based external Haller Index (EHI) measurements to quantify the severity of pectus excavatum. CR and CT based conventional Haller Indices (HI) are used as reference method. CR and CT are both used as reference method, as the work-up of pectus patients in our centre is dependent of age. Subsequently, two groups are created: (A) patients under 18 years of age that receive a frontal (anteroposterior) and sagittal chest radiography, and (B) patients aged 18 years or older that receive a chest CT scan. In this study, patients are their own control. To obtain optical surface images, a handheld 3D scanner is used. During acquisition, subjects will be standing in an upright position with arms abducted. Standard routinely used protocols are used to acquire chest radiographies and CT scans. The HI is obtained from all chest radiographies and CT scans, calculated by dividing the widest thoracic transverse diameter by the anteroposterior distance, measured from the posterior surface of sternum to the anterior surface of the vertebral body. The EHI, a modified measurement to assess pectus deformity, is used to quantify PE severity based on 3D optical surface images. The EHI is calculated by dividing the widest external thoracic transverse diameter by the distance between the external deepest point or point of maximal protrusion and external vertebral body. The EHI is also calculated from the available chest radiographies and CT scans. All measurements will be performed by three blinded observers that are not responsible to perform a comprehensive interpretation of the study. Following acquisition of all indices, the inter-observer reliability is calculated using the intraclass correlation coefficient. Based on the means, a receiver-operating characteristic (ROC)-curve is created for the 3D scan based EHI measurements, utilizing the surgical indication based on CR and CT (HI larger or equal to 3.25) images as gold standard. The optimal cut-off value, obtained from the ROC-curve is subsequently used to determine the 3D optical surface images' diagnostic accuracy.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 28 participants
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Diagnostic
  • Official Title: Three-dimensional Optical Surface Imaging as a Diagnostic Tool for Severity Quantification and Clinical Decision Making in Pectus Excavatum
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/treatment
Other: Patients aged 18 years or older
Group B consists of patients that receive a CT scan in the current work-up of PE.
Other: 3D optical surface image
3D optical surface images will be acquired and used to calculate the EHI

Radiation: CT scan
CT scans will be acquired and used to calculate the HI and EHI
Other: Patients under 18 years of age
Group A consists of patients that receive a chest radiography in the current work-up of PE.
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
Outcome Measures
  • Primary Outcome Measures: 1. Diagnostic accuracy of the EHI, calculated from 3D optical surface images [ Time Frame: 1 year ]
    Dependent of age, the CR or CT based HI is utilized as reference method
  • Secondary Outcome Measures: 1. Inter-observer reliability [ Time Frame: 1 year ]
    Inter-observer reliability of CR, CT and 3D image derived (external) Haller Inidices, obtained by 3 observers
  • 2. Correlation of CT scan derived HI and EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • 3. Correlation of CT scan derived EHI and 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • 4. Correlation of CT and CR derived HI with 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • 5. Absolute agreement of CT scan derived EHI and 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Assessed by the intraclass correlation coefficient
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion criteria:

- All patients that visit the Zuyderland Medical Centre outpatient clinic for evaluation
of their pectus excavatum.

- No age restrictions were imposed, however, to be eligible, it was mandatory to be able
to stand still in and upright position for 60 seconds.

Exclusion criteria:

- Patients that suffer from any form of light hypersensitivity or epilepsy were not
considered while 3D optical surface images were acquired with the use of structured,
flashing light.

Contacts and Locations
Contacts

Contact: Jean Daemen +31884597777 j.daemen@zuyderland.nl

Locations

Netherlands, Limburg
Zuyderland Medical Centre
Heerlen

Sponsors and Collaborators

Zuyderland Medisch Centrum

More Information
  • Responsible Party: Zuyderland Medisch Centrum
  • ClinicalTrials.gov Identifier: NCT03926078 History of Changes
  • Other Study ID Numbers: METCZ20190048
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 2, 2020
  • Last Verified: July 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Zuyderland Medisch Centrum: Haller Index
    Optical Imaging
    Torso Topography
    Three-dimensional Surface Scan
    Diagnostic accuracy
  • Additional relevant MeSH terms: Funnel Chest