Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses

April 20, 2021 updated by: Monica Sobhy Khalaf Boles, Assiut University
Our aim is to assess the role of the gray scale and color Doppler ultrasound in diagnosis of the different pediatric neck masses .

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Neck masses are a common occurrence in the pediatric population and often represent a diagnostic challenge for the clinician involved . fortunately , the vast majority of these lesions are ultimately proven to be benign in nature (1).

Even though clinical examination and patient's history are the first and indispensable steps in the initial diagnosis, the role of imaging is crucial, not only to determine whether a mass represents a true tumour or not , but also to achieve a more correct diagnosis and determine the extension of the lesion and its relation with the nearby anatomic structures (2).

Ultrasound (US) should serve as the primary initial imaging modality in children for palpable masses and assessment of superficial glandular structures. Because of the smaller neck size and less subcutaneous fat, sonographic penetration and resolution is generally improved as compared with adults (3 ).

Doppler imaging can also elucidate how flow is distributed within a mass may have diagnostic significance and help us in determining the nature of the lesion as well as it is of great importance in assessment of vascular lesions (4)

Though ultrasound is most common method used for evaluation of pediatric neck masses , and CT as well as MRI are used as an additional tool when necessary ( 3 ) , few studies have looked at the sensitivity and specificity of the different imaging modalities of the pediatric neck masses and most studies have investigated the epidemiology of the pediatric neck masses (5) which make histopathological diagnosis still the gold standard in distinguishing the etiology of pediatric neck masses and ruling out malignant disease (6)

Study Type

Observational

Enrollment (Anticipated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric patients with neck masses attending at outpatient clinics at assiut university pediatric hospital.

Description

Inclusion Criteria:

- Clinical cases who are suspected for and provisionally diagnosed for "neck swelling" in children (below age of 18 years).

Exclusion Criteria:

  1. Patients with conditions that may hinder ultrasound examination like subcutaneous emphysema and thick skin scarring.
  2. Patients who are unwilling/uncooperative or have not given consent for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Using gray scale ultrasound to determine the consistency of neck masses in children.
Time Frame: baseline
determination if the lesion is solid (hyperechoic, hypoechoic or isoechoic in comparison to adjacent neck muscles) or cystic (anechoic) or mixed in consistency.
baseline
determination of the extension of neck masses in children.
Time Frame: baseline
through assessment of height, length and width in centimeters.
baseline
determination of the definition of neck masses in children,
Time Frame: baseline
whether it is well defined (rounded, oval or lobulated) , ill-defined(speculated or irregular).
baseline
using color doppler ultrasound in assessment neck masses in children.
Time Frame: baseline
increased or decreased vascularity depending on number of vessels and the nature of color wave (arterial or venous),
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Samy AbdElAziz, PhD, Assiut University
  • Study Director: Hazem Abo Zeid, PhD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Us in pediatric neck masses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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