NCT04856020

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

February 12, 2021

Last Update Submit

April 20, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • determination of the extension of neck masses in children.

    through assessment of height, length and width in centimeters.

    baseline

  • determination of the definition of neck masses in children,

    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.

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

    baseline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 30643937BACKGROUND
  • 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.

    PMID: 31187354BACKGROUND
  • 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.

    PMID: 21807165BACKGROUND
  • 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.

    PMID: 25439556BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Samy AbdElAziz, PhD

    Assiut University

    STUDY CHAIR
  • Hazem Abo Zeid, PhD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

April 22, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

April 22, 2021

Record last verified: 2021-04