NCT03926078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

April 18, 2019

Last Update Submit

July 1, 2020

Conditions

Pectus Excavatum

Keywords

Haller IndexOptical ImagingTorso TopographyThree-dimensional Surface ScanDiagnostic accuracy

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (5)

  • Inter-observer reliability

    1 year

  • Correlation of CT scan derived HI and EHI

    1 year

  • Correlation of CT scan derived EHI and 3D optical surface image derived EHI

    1 year

  • Correlation of CT and CR derived HI with 3D optical surface image derived EHI

    1 year

  • Absolute agreement of CT scan derived EHI and 3D optical surface image derived EHI

    1 year

Study Arms (2)

Patients under 18 years of age

OTHER

Group A consists of patients that receive a chest radiography in the current work-up of PE.

Other: 3D optical surface imageRadiation: 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.

Other: 3D optical surface imageRadiation: CT scan

Interventions

3D optical surface imageOTHER

3D optical surface images will be acquired and used to calculate the EHI

Patients aged 18 years or olderPatients under 18 years of age
Chest radiographyRADIATION

Chest radiographies will be acquired and used to calculated the HI and EHI

Patients under 18 years of age
CT scanRADIATION

CT scans will be acquired and used to calculate the HI and EHI

Patients aged 18 years or older

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Jean Daemen

CONTACT

+31884597777j.daemen@zuyderland.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All measurements will be performed by three blinded observers that are not responsible to perform a comprehensive interpretation of the study.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 24, 2019

Study Start

August 21, 2019

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

July 2, 2020

Record last verified: 2020-07

Locations

NL(1)