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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04856020
Collaborator
(none)
96
25

Study Details

Study Description

Brief Summary

Our aim is to assess the role of the gray scale and color Doppler ultrasound in diagnosis of the different pediatric neck masses .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    96 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses
    Anticipated Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Using gray scale ultrasound to determine the consistency of neck masses in children. [baseline]

      determination if the lesion is solid (hyperechoic, hypoechoic or isoechoic in comparison to adjacent neck muscles) or cystic (anechoic) or mixed in consistency.

    2. determination of the extension of neck masses in children. [baseline]

      through assessment of height, length and width in centimeters.

    3. determination of the definition of neck masses in children, [baseline]

      whether it is well defined (rounded, oval or lobulated) , ill-defined(speculated or irregular).

    4. using color doppler ultrasound in assessment neck masses in children. [baseline]

      increased or decreased vascularity depending on number of vessels and the nature of color wave (arterial or venous),

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Monica Sobhy Khalaf Boles, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04856020
    Other Study ID Numbers:
    • Us in pediatric neck masses
    First Posted:
    Apr 22, 2021
    Last Update Posted:
    Apr 22, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 22, 2021