Non-invasive Clinical Pectus Index as a Measurement of Severity in Pectus

NCT02552186 | Completed

• 1 other identifier: IRB00067521
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

Pectus excavatum (PE), the most common congenital chest wall deformity, requires surgical repair when the degree of deformity is severe. Currently, the Pectus Index (PI) is used to classify PE severity. Calculation of the PI requires cross-sectional imaging of the chest, usually with computed tomography (CT) or Magnetic Resonance Imaging (MRI), to obtain the necessary measurements. However, CT delivers a high dose of ionizing radiation, which carries cumulative long-term risks of malignancy and MRI can be costly. The purpose of this study is to develop a method whereby accurate chest wall measurements can be obtained to quantify PE severity without the need for cross-sectional imaging.

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (3)

• Sensitivity of clinically-derived threshold versus CT/MRI-derived thresholds

  Sensitivity refers to the ability of the test to correctly identify those patients with the disease.

  5 years

• Specificity of clinically-derived threshold versus CT/MRI-derived thresholds

  Specificity refers to the ability of the test to correctly identify those patients without the disease.

  5 years

• Receiver operator characteristic curve of clinically-derived threshold versus CT/MRI-derived thresholds

  plot of the true positive rate against the false positive rate for the different possible cutpoints of a diagnostic test.

  5 years

Secondary Outcomes (3)

• Correlation coefficient

  5 years

• Cohen's Kappa coefficient

  5 years

• Agreement between Clinical Pectus Index (CPI) and Pectus Index (PI)-derived from CT or MRI

  5 years

Study Arms (2)

Pectus Excavatum Group

ACTIVE COMPARATOR

The first group (PE Group) will consist of patients presenting to the All Children's Hospital Johns Hopkins Medicine (ACH JHM) Pediatric Surgery or Cardiac Surgery Clinics and the outpatient clinic system at Johns Hopkins Hospital for evaluation of pectus excavatum. Clinical measurements will be obtained using calipers.

Other: Caliper measurement

Control Group

NO INTERVENTION

The second group (Control Group) will be age and gender matched patients presenting to the Radiology department of ACH JHM undergoing CT chest for indications other than chest wall deformity.

Interventions

Caliper measurement OTHER

Clinical caliper measurements will be taken and used to calculate the Clinical PI

Pectus Excavatum Group

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Group A (PE Group): All patients evaluated in the ACH JHM Pediatric Surgery or Cardiac Surgery Clinics, as well as in the outpatient clinic system at Johns Hopkins Hospital, for surgical correction of Pectus Excavatum.
• Group B (Control Group): Age and gender matched patients who undergo chest CT at the ACH JHM Radiology Department for indications other than Pectus Excavatum.

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nicole Chandler, MD

  JHACH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

US (1)