Pectus Excavatum3D PECTUSNCT03926078
Three-dimensional Optical Surface Imaging as a Diagnostic Tool in Pectus Excavatum
A study testing 3D optical surface image, Chest radiography and CT scan in people with Pectus Excavatum, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- 3D optical surface image, Chest radiography and CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Aug 2019to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medical Centre
Heerlen, Limburg, 6419PC
Jean Daemen, +314597777, j.daemen@zuyderland.nl
About this study
Official title: Three-dimensional Optical Surface Imaging as a Diagnostic Tool for Severity Quantification and Clinical Decision Making in Pectus Excavatum
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.
Read the 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.
- Conditions
- Pectus Excavatum
- Being tested
- 3D optical surface image, Chest radiography, CT scan
- Keywords
- Haller Index, Optical Imaging, Torso Topography, Three-dimensional Surface Scan, Diagnostic accuracy
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D optical surface imageOther
3D optical surface images will be acquired and used to calculate the EHI
Chest radiographyRadiation
Chest radiographies will be acquired and used to calculated the HI and EHI
CT scanRadiation
CT scans will be acquired and used to calculate the HI and EHI
| Study group | Role | What they receive |
|---|---|---|
| Patients under 18 years of age | Other | Group A consists of patients that receive a chest radiography in the current work-up of PE. Receives: Other: 3D optical surface image; Radiation: Chest radiography |
| Patients aged 18 years or older | Other | Group B consists of patients that receive a CT scan in the current work-up of PE. Receives: Other: 3D optical surface image; Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Inter-observer reliability
Inter-observer reliability of CR, CT and 3D image derived (external) Haller Inidices, obtained by 3 observers
Measured: 1 year
Correlation of CT scan derived HI and EHI
Correlation is assessed by the Pearson's correlation coefficient
Measured: 1 year
Correlation of CT scan derived EHI and 3D optical surface image derived EHI
Correlation is assessed by the Pearson's correlation coefficient
Measured: 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
Measured: 1 year
Absolute agreement of CT scan derived EHI and 3D optical surface image derived EHI
Assessed by the intraclass correlation coefficient
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start21 Aug 2019
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926078
- Sponsor's protocol ID
- METCZ20190048
- Acronym
- 3D PECTUS
- Status last verified
- Jul 2020
- First submitted
- 18 Apr 2019
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Optical Surface Imaging as a Diagnostic Tool for Severity Quantification and Clinical Decision Making in Pectus Excavatum
- ClinicalTrials.gov ID
- NCT03926078
- Acronym / sponsor ID
- 3D PECTUS / METCZ20190048
- Conditions
- Pectus Excavatum
- Keywords
- Haller Index, Optical Imaging, Torso Topography, Three-dimensional Surface Scan, Diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under 18 years of age | Other | Other: 3D optical surface image, Radiation: Chest radiographyGroup A consists of patients that receive a chest radiography in the current work-up of PE. |
| Patients aged 18 years or older | Other | Other: 3D optical surface image, Radiation: CT scanGroup B consists of patients that receive a CT scan in the current work-up of PE. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D optical surface image3D optical surface images will be acquired and used to calculate the EHI | Other | Patients aged 18 years or older, Patients under 18 years of age |
| Chest radiographyChest radiographies will be acquired and used to calculated the HI and EHI | Radiation | Patients under 18 years of age |
| CT scanCT scans will be acquired and used to calculate the HI and EHI | Radiation | Patients aged 18 years or older |
Primary outcome
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
5 secondary outcomes
Inter-observer reliability
Time frame: 1 year
Correlation of CT scan derived HI and EHI
Time frame: 1 year
Correlation of CT scan derived EHI and 3D optical surface image derived EHI
Time frame: 1 year
Correlation of CT and CR derived HI with 3D optical surface image derived EHI
Time frame: 1 year
Absolute agreement of CT scan derived EHI and 3D optical surface image derived EHI
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D optical surface image, Chest radiography and CT scan in people with Pectus Excavatum, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Daemen (+31884597777, j.daemen@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the EHI, calculated from 3D optical surface images (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.