An interventional study of 3D optical surface image and Chest radiography in Pectus Excavatum, sponsored by Zuyderland Medisch Centrum. Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2020-07-02.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Diagnostic
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.
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 28 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion criteria:
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A consists of patients that receive a chest radiography in the current work-up of PE.
Other: 3D optical surface image · Radiation: Chest radiography
Group B consists of patients that receive a CT scan in the current work-up of PE.
Other: 3D optical surface image · Radiation: CT scan
3D optical surface images will be acquired and used to calculate the EHI
Chest radiographies will be acquired and used to calculated the HI and EHI
CT scans will be acquired and used to calculate the HI and EHI
Diagnostic accuracy of the EHI, calculated from 3D optical surface images
Dependent of age, the CR or CT based HI is utilized as reference method
Time frame: 1 year
Inter-observer reliability
Inter-observer reliability of CR, CT and 3D image derived (external) Haller Inidices, obtained by 3 observers
Time frame: 1 year
Correlation of CT scan derived HI and EHI
Correlation is assessed by the Pearson's correlation coefficient
Time frame: 1 year
Correlation of CT scan derived EHI and 3D optical surface image derived EHI
Correlation is assessed by the Pearson's correlation coefficient
Time frame: 1 year
Correlation of CT and CR derived HI with 3D optical surface image derived EHI
Correlation is assessed by the Pearson's correlation coefficient
Time frame: 1 year
Absolute agreement of CT scan derived EHI and 3D optical surface image derived EHI
Assessed by the intraclass correlation coefficient
Time frame: 1 year
Started Aug 2019 (actual). Primary completion is estimated for Feb 2021, 18 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 18 months is below that.
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum