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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

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 Intervention/treatment Phase
Pectus Excavatum Other: 3D optical surface image Radiation: Chest radiography Radiation: CT scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
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
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 21, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




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



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926078


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

Locations
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Netherlands
Zuyderland Medical Centre Recruiting
Heerlen, Limburg, Netherlands, 6419PC
Contact: Jean Daemen    +314597777    j.daemen@zuyderland.nl   
Sponsors and Collaborators
Zuyderland Medisch Centrum
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Responsible Party: Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT03926078    
Other Study ID Numbers: METCZ20190048
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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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:
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Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities