Pediatric TumorNCT04856020
Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses
An observational study of Pediatric Tumor, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Tumor
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric patients with neck masses attending at outpatient clinics at assiut university pediatric hospital.
Who may be able to join
- Clinical cases who are suspected for and provisionally diagnosed for "neck swelling" in children (below age of 18 years).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Our aim is to assess the role of the gray scale and color Doppler ultrasound in diagnosis of the different pediatric neck masses .
Read the 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)
- Conditions
- Pediatric Tumor
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
determination of the extension of neck masses in children.
through assessment of height, length and width in centimeters.
Measured: baseline
determination of the definition of neck masses in children,
whether it is well defined (rounded, oval or lobulated) , ill-defined(speculated or irregular).
Measured: 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),
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric TumorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Sobhy Khalaf Boles, Assiut University
- Investigators
- Samy AbdElAziz, PhD, Study chair, Assiut UniversityHazem Abo Zeid, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856020
- Sponsor's protocol ID
- Us in pediatric neck masses
- Status last verified
- Apr 2021
- First submitted
- 12 Feb 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30643937Toma 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.
PubMed 31187354Friedman 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.
PubMed 21807165Stern 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.
PubMed 25439556
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses
- ClinicalTrials.gov ID
- NCT04856020
- Acronym / sponsor ID
- Us in pediatric neck masses
- Conditions
- Pediatric Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric patients with neck masses attending at outpatient clinics at assiut university pediatric hospital.
Key inclusion criteria (1 listed)
- Clinical cases who are suspected for and provisionally diagnosed for "neck swelling" in children (below age of 18 years).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
determination of the extension of neck masses in children.
Time frame: baseline
through assessment of height, length and width in centimeters.
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).
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),
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Background: PubMed 30643937Riva 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.
- Background: PubMed 31187354Toma 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.
- Background: PubMed 21807165Friedman 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.
- Background: PubMed 25439556Stern 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samy AbdElAziz, PhD study chair
Assiut University
Hazem Abo Zeid, PhD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Tumor, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Sobhy (+2001278489110, monica.sobhy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using gray scale ultrasound to determine the consistency of neck masses in children. (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04856020, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.