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Three-dimensional Optical Surface Imaging as a Diagnostic Tool in Pectus Excavatum (3D PECTUS)

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ClinicalTrials.gov Identifier: NCT03926078
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Zuyderland Medisch Centrum

Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date July 2, 2020
Actual Study Start Date  ICMJE August 21, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Correlation of chest radiography derived HI and 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • Correlation of CT scan derived HI and 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Inter-observer reliability [ Time Frame: 1 year ]
    Inter-observer reliability of CR, CT and 3D image derived (external) Haller Inidices, obtained by 3 observers
  • Correlation of CT scan derived HI and EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • 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
  • 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
  • Absolute agreement of CT scan derived EHI and 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Assessed by the intraclass correlation coefficient
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Correlation of chest radiography derived HI and EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • Correlation of chest radiography derived EHI and 3D optical surface image derived EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • Correlation of CT scan derived HI and EHI [ Time Frame: 1 year ]
    Correlation is assessed by the Pearson's correlation coefficient
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three-dimensional Optical Surface Imaging as a Diagnostic Tool in Pectus Excavatum
Official Title  ICMJE Three-dimensional Optical Surface Imaging as a Diagnostic Tool for Severity Quantification and Clinical Decision Making in Pectus Excavatum
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
All measurements will be performed by three blinded observers that are not responsible to perform a comprehensive interpretation of the study.
Primary Purpose: Diagnostic
Condition  ICMJE Pectus Excavatum
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Patients under 18 years of age
    Group A consists of patients that receive a chest radiography in the current work-up of PE.
    Interventions:
    • Other: 3D optical surface image
    • Radiation: Chest radiography
  • Patients aged 18 years or older
    Group B consists of patients that receive a CT scan in the current work-up of PE.
    Interventions:
    • Other: 3D optical surface image
    • Radiation: CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jean Daemen +31884597777 j.daemen@zuyderland.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926078
Other Study ID Numbers  ICMJE METCZ20190048
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zuyderland Medisch Centrum
Study Sponsor  ICMJE Zuyderland Medisch Centrum
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zuyderland Medisch Centrum
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP