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

NCT ID: NCT04856020

Last Updated: 2021-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Monica Sobhy Khalaf Boles

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Samy AbdElAziz, PhD

Role: STUDY_CHAIR

Assiut University

Hazem Abo Zeid, PhD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Monica Sobhy

Role: CONTACT

+2001278489110

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30643937 (View on PubMed)

Toma 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.

Reference Type BACKGROUND
PMID: 31187354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21807165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25439556 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Us in pediatric neck masses

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.