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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04856020
Other study ID # Us in pediatric neck masses
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date May 2023

Study information

Verified date April 2021
Source Assiut University
Contact Monica Sobhy
Phone +2001278489110
Email monica.sobhy94@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date May 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Friedman ER, John SD. Imaging of pediatric neck masses. Radiol Clin North Am. 2011 Jul;49(4):617-32, v. doi: 10.1016/j.rcl.2011.05.005. Review. — View Citation

Riva G, Sensini M, Peradotto F, Scolfaro C, Di Rosa G, Tavormina P. Pediatric neck masses: how clinical and radiological features can drive diagnosis. Eur J Pediatr. 2019 Apr;178(4):463-471. doi: 10.1007/s00431-018-3305-9. Epub 2019 Jan 14. — View Citation

Stern JS, Ginat DT, Nicholas JL, Ryan ME. Imaging of pediatric head and neck masses. Otolaryngol Clin North Am. 2015 Feb;48(1):225-46. doi: 10.1016/j.otc.2014.09.015. Review. — View Citation

Tomà P, Esposito F, Granata C, Paolantonio G, Terranova MC, Lo Re G, Ferrara D, Rollo M, Zeccolini M, Salerno S. Up-to-date imaging review of paediatric soft tissue vascular masses, focusing on sonography. Radiol Med. 2019 Oct;124(10):935-945. doi: 10.1007/s11547-019-01050-8. Epub 2019 Jun 11. Review. — View Citation

Outcome

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