LipomaNCT07734805
Radiological Diagnosis of Pediatric Neck Swellings
An observational study of Lipoma and Branchial Cleft Anomalies, run by Sohag University at 1 site in Egypt.
Trial summary
Various diagnostic imaging modalities have been utilized in the assessment of pediatric neck lesions, including gray-scale and Doppler ultrasonography, conventional and three-dimensional computed tomography (CT), magnetic resonance imaging (MRI), and MR angiography, each offering distinct advantages and limitations. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Lipoma, Branchial Cleft Anomalies, Cystic Hygroma (Macro-cystic Lymphatic Malformation)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to 1 Feb 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients referred from pediatrics, ENT, surgery, oncology or emergency departments for radiological evaluation of a neck swelling/mass
Who may be able to join
- Pediatric patients referred from pediatrics, ENT, surgery, oncology or emergency departments for radiological evaluation of a neck swelling/mass
Who cannot join
- Previous surgery (post operative patients).
- Contraindications to intravenous contrast administration when contrast enhanced studies are required (e.g. history of severe contrast allergy).
- Contraindication to MRI (e.g., severe claustrophobia non-manageable by sedation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Diagnostic Imaging in Characterization of Pediatric Neck Swellings
Various diagnostic imaging modalities have been utilized in the assessment of pediatric neck lesions, including gray-scale and Doppler ultrasonography, conventional and three-dimensional computed tomography (CT), magnetic resonance imaging (MRI), and MR angiography, each offering distinct advantages and limitations.
Read the detailed description
Although gray-scale ultrasonography and duplex imaging are considered the first-line modalities for evaluating superficial neck masses due to their accessibility, feasibility, and cost-effectiveness, the depth of high-frequency transducers is limited, particularly in large lesions with uncertain origin or extent. Consequently, cross-sectional imaging modalities such as CT and MRI play an important complementary role by improving diagnostic accuracy and providing detailed assessment of deeper structural involvement. [2,3]
Radiological characterization aims eventually to guide management by identifying the most appropriate subsequent step, which may include clinical observation, interval imaging follow-up, tissue sampling, surgical intervention, embolization, or sclerotherapy.
- Conditions
- Lipoma, Branchial Cleft Anomalies, Cystic Hygroma (Macro-cystic Lymphatic Malformation), Rhabdomyosarcoma, Lymphadenitis, Neck Abscess
- Keywords
- neck swellings, neck abscess, lymphadenitis, branchial cleft cyst, cervical lymphadenitis, nodal abscess, chondrosacroma, neck mass, hemangioma, thyroglossal duct cyst
- Medical subject headings
- Lipoma, Branchial Cleft Anomalies, Lymphangioma, Cystic, Rhabdomyosarcoma, Lymphadenitis, Chondrosarcoma, Extraskeletal Myxoid, Thyroglossal Cyst, Branchioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients with neck swellings | Pediatric patients referred to Sohag University Hospital for radiological evaluation of a neck swelling or mass. Patients will undergo clinical assessment and appropriate imaging evaluation, including gray-scale and Doppler ultrasonography as the initial imaging modality, with CT and/or MRI performed when clinically indicated. Imaging findings will be assessed for lesion detection, anatomical localization, tissue characterization, differential diagnosis, and assessment of involvement of adjacent structures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of tissue characterization of pediatric neck swellings
Accuracy of multimodality imaging in characterizing pediatric neck swellings according to their imaging features and tissue composition, including cystic, solid, vascular, inflammatory, or other relevant characteristics, compared with the final diagnosis based on histopathological examination, microbiological assessment, surgical findings, or clinical and imaging follow-up, as applicable.
Measured: From baseline imaging assessment until establishment of the final diagnosis, or up to 6 months after initial imaging, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start20 Feb 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipomaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohamed Hassan, Sohag University
- Investigators
- Mohamad Zaki Ali, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734805
- Sponsor's protocol ID
- Soh-Med-26-7-5MS
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared with other researchers. Data will be analyzed and reported in aggregate form, and participant confidentiality will be maintained. Any data used for analysis will be anonymized and securely stored in accordance with institutional ethical requirements and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diagnostic Imaging in Characterization of Pediatric Neck Swellings
- ClinicalTrials.gov ID
- NCT07734805
- Acronym / sponsor ID
- Soh-Med-26-7-5MS
- Conditions
- Lipoma, Branchial Cleft Anomalies, Cystic Hygroma (Macro-cystic Lymphatic Malformation), Rhabdomyosarcoma, Lymphadenitis, Neck Abscess
- Keywords
- neck swellings, neck abscess, lymphadenitis, branchial cleft cyst, cervical lymphadenitis, nodal abscess, chondrosacroma, neck mass
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
Various diagnostic imaging modalities have been utilized in the assessment of pediatric neck lesions, including gray-scale and Doppler ultrasonography, conventional and three-dimensional computed tomography (CT), magnetic resonance imaging (MRI), and MR angiography, each offering distinct advantages and limitations.
Detailed description
Although gray-scale ultrasonography and duplex imaging are considered the first-line modalities for evaluating superficial neck masses due to their accessibility, feasibility, and cost-effectiveness, the depth of high-frequency transducers is limited, particularly in large lesions with uncertain origin or extent. Consequently, cross-sectional imaging modalities such as CT and MRI play an important complementary role by improving diagnostic accuracy and providing detailed assessment of deeper structural involvement. [2,3]
Radiological characterization aims eventually to guide management by identifying the most appropriate subsequent step, which may include clinical observation, interval imaging follow-up, tissue sampling, surgical intervention, embolization, or sclerotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with neck swellings | – | –Pediatric patients referred to Sohag University Hospital for radiological evaluation of a neck swelling or mass. Patients will undergo clinical assessment and appropriate imaging evaluation, including gray-scale and Doppler ultrasonography as the initial imaging modality, with CT and/or MRI performed when clinically indicated. Imaging findings will be assessed for lesion detection, anatomical localization, tissue characterization, differential diagnosis, and assessment of involvement of adjacent structures. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients referred from pediatrics, ENT, surgery, oncology or emergency departments for radiological evaluation of a neck swelling/mass
Key inclusion criteria (1 listed)
- Pediatric patients referred from pediatrics, ENT, surgery, oncology or emergency departments for radiological evaluation of a neck swelling/mass
Key exclusion criteria (3 listed)
- Previous surgery (post operative patients).
- Contraindications to intravenous contrast administration when contrast enhanced studies are required (e.g. history of severe contrast allergy).
- Contraindication to MRI (e.g., severe claustrophobia non-manageable by sedation).
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
Diagnostic accuracy of tissue characterization of pediatric neck swellings
Time frame: From baseline imaging assessment until establishment of the final diagnosis, or up to 6 months after initial imaging, whichever comes first.
Accuracy of multimodality imaging in characterizing pediatric neck swellings according to their imaging features and tissue composition, including cystic, solid, vascular, inflammatory, or other relevant characteristics, compared with the final diagnosis based on histopathological examination, microbiological assessment, surgical findings, or clinical and imaging follow-up, as applicable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared with other researchers. Data will be analyzed and reported in aggregate form, and participant confidentiality will be maintained. Any data used for analysis will be anonymized and securely stored in accordance with institutional ethical requirements and applicable data protection regulations.
Related trials for Lipoma
RecruitingPhase 1
Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma
Lipoma, Submental Fullness
Not yet recruiting
Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Subcutaneous Lipomas
Lipoma
Recruiting
RFA for Superficial Lipomas
Lipoma
RecruitingPhase 1/2
Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride
Lipoma
Recruiting
MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment
Spinal Cord Tumors
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.
Mohamad Zaki Ali, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipoma and Branchial Cleft Anomalies, run by Sohag University at 1 site in Egypt.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of tissue characterization of pediatric neck swellings (time frame: From baseline imaging assessment until establishment of the final diagnosis, or up to 6 months after initial imaging, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.