Superficial Soft Tissue MassesMRI/US in SSTMNCT07294248
Role of MRI and US in Superficial Soft Tissue Masses
An observational study of Superficial Soft Tissue Masses, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this observational study to evaluate the accuracy of Magnetic Resonance Imaging and Ultrasonography in characterization of superficial soft tissue masses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superficial Soft Tissue Masses
- What is being tested?
- Diagnostic imaging (US and MRI).
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting with clinically or radiologically suspected superficial soft tissue masses who are referred for diagnostic ultrasound and MRI evaluation at the hospital during the study period. The study population includes adults and children meeting the eligibility criteria and undergoing imaging as part of routine diagnostic assessment.
Who may be able to join
- Patients who suffer from superficial soft tissue lesions in both sex and of any age group, will be included in the study.
Who cannot join
- Patients unwilling to complete study.
- Patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI, will be evaluated by US.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag, Sohag Governorate
Mariam Sobhy Aziz, Resident, 01212050629, mariam_sobhy_post@med.sohag.edu.eg
mariam_sobhy_post@med.sohag.edu.eg
About this study
Official title: Diagnostic Role of Magnetic Resonance Imaging and Ultrasonography in Characterization of Superficial Soft Tissue Masses.
The goal of this observational study to evaluate the accuracy of Magnetic Resonance Imaging and Ultrasonography in characterization of superficial soft tissue masses.
Read the detailed description
This study is a prospective observational study aiming to evaluate and compare the diagnostic roles of magnetic resonance imaging (MRI) and ultrasound (US) in the characterization of superficial soft tissue masses. The study will be conducted in [ Sohag ] over a period of [ 6 Months].
Participants Consecutive patients presenting with superficial soft tissue masses (located within the subcutaneous tissue. Inclusion criteria include Patients who suffer from superficial soft tissue lesions measurable by both MRI and US in both sex and of any age group, will be included in the study , Exclusion criteria include Patients unwilling to complete study, Patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI, will be evaluated by US.
Objectives
- Primary objective: To determine the added value of MRI compared with ultrasound in accurate characterization of superficial soft tissue masses (benign vs malignant features).
- Secondary objectives:
- Assess concordance between MRI and US in differentiating cystic versus solid lesions.
- Identify specific imaging features on MRI and US that best predict malignant potential.
- Evaluate interobserver agreement for MRI and US interpretations.
Methods Imaging Protocols
- Ultrasound: High-resolution ultrasound with Doppler will be performed to assess size, echotexture, margins, internal septations, vascularity, and presence of calcifications. Lesions will be categorized as solid, cystic, or complex.
- MRI: MRI protocols will include T1-weighted, T2-weighted, STIR, and post-contrast sequences, with assessment of lesion margins, internal composition, enhancement pattern, diffusion characteristics where available, and involvement of adjacent structures.
Data Collection and Outcomes
- Demographic data, lesion characteristics (size, location, depth), imaging features, and final diagnosis will be recorded.
- Primary outcome: Diagnostic accuracy (sensitivity, specificity, positive and negative predictive values) of MRI and US individually and in combination for distinguishing malignant from benign masses.
- Secondary outcomes: Agreement between modalities; correlation of specific imaging features with histopathology if available.
Data Analysis The collected data will be statistically analyzed using SPSS. Chi-square (X2 analysis) contingency analysis will be used. Results will be discussed. Conclusions and recommendations will be suggested based on the results.
Ethical Considerations
- The study will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants. The study protocol has been or will be approved by the [Institutional Review Board/Ethics Committee].
- Conditions
- Superficial Soft Tissue Masses
- Being tested
- Diagnostic imaging (US and MRI).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging (US and MRI).Other
Ultrasonography and MRI are performed as part of routine diagnostic evaluation, these are not therapeutic interventions
| Study group | Role | What they receive |
|---|---|---|
| Patients with superficial soft tissue masses | Participants diagnosed with superficial soft tissue masses undergoing ultrasound and MRI for diagnostic characterization. Receives: Other: Diagnostic imaging (US and MRI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Ultrasound and MRI in characterization of superficial soft tissue masses.
Evaluation of the ability of ultrasound and MRI to correctly characterize superficial soft tissue masses. Diagnostic accuracy measures will include sensitivity, specificity, positive predictive value, and negative predictive value compared to the final reference diagnosis.
Measured: During initial diagnostic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Soft Tissue MassesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Sobhy Aziz, Sohag University
- Investigators
- Mohamed Hassan Alam-Eldeen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294248
- Sponsor's protocol ID
- Soh-Med--25-11-15MS
- Acronym
- MRI/US in SSTM
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy and confidentiality considerations
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Role of Magnetic Resonance Imaging and Ultrasonography in Characterization of Superficial Soft Tissue Masses.
- ClinicalTrials.gov ID
- NCT07294248
- Acronym / sponsor ID
- MRI/US in SSTM / Soh-Med--25-11-15MS
- Conditions
- Superficial Soft Tissue Masses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 Dec 2025 (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.
The goal of this observational study to evaluate the accuracy of Magnetic Resonance Imaging and Ultrasonography in characterization of superficial soft tissue masses.
Detailed description
This study is a prospective observational study aiming to evaluate and compare the diagnostic roles of magnetic resonance imaging (MRI) and ultrasound (US) in the characterization of superficial soft tissue masses. The study will be conducted in [ Sohag ] over a period of [ 6 Months].
Participants Consecutive patients presenting with superficial soft tissue masses (located within the subcutaneous tissue. Inclusion criteria include Patients who suffer from superficial soft tissue lesions measurable by both MRI and US in both sex and of any age group, will be included in the study , Exclusion criteria include Patients unwilling to complete study, Patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI, will be evaluated by US.
Objectives
- Primary objective: To determine the added value of MRI compared with ultrasound in accurate characterization of superficial soft tissue masses (benign vs malignant features).
- Secondary objectives:
- Assess concordance between MRI and US in differentiating cystic versus solid lesions.
- Identify specific imaging features on MRI and US that best predict malignant potential.
- Evaluate interobserver agreement for MRI and US interpretations.
Methods Imaging Protocols
- Ultrasound: High-resolution ultrasound with Doppler will be performed to assess size, echotexture, margins, internal septations, vascularity, and presence of calcifications. Lesions will be categorized as solid, cystic, or complex.
- MRI: MRI protocols will include T1-weighted, T2-weighted, STIR, and post-contrast sequences, with assessment of lesion margins, internal composition, enhancement pattern, diffusion characteristics where available, and involvement of adjacent structures.
Data Collection and Outcomes
- Demographic data, lesion characteristics (size, location, depth), imaging features, and final diagnosis will be recorded.
- Primary outcome: Diagnostic accuracy (sensitivity, specificity, positive and negative predictive values) of MRI and US individually and in combination for distinguishing malignant from benign masses.
- Secondary outcomes: Agreement between modalities; correlation of specific imaging features with histopathology if available.
Data Analysis The collected data will be statistically analyzed using SPSS. Chi-square (X2 analysis) contingency analysis will be used. Results will be discussed. Conclusions and recommendations will be suggested based on the results.
Ethical Considerations
- The study will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants. The study protocol has been or will be approved by the [Institutional Review Board/Ethics Committee].
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with superficial soft tissue masses | – | Other: Diagnostic imaging (US and MRI).Participants diagnosed with superficial soft tissue masses undergoing ultrasound and MRI for diagnostic characterization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting with clinically or radiologically suspected superficial soft tissue masses who are referred for diagnostic ultrasound and MRI evaluation at the hospital during the study period. The study population includes adults and children meeting the eligibility criteria and undergoing imaging as part of routine diagnostic assessment.
Key inclusion criteria (1 listed)
- Patients who suffer from superficial soft tissue lesions in both sex and of any age group, will be included in the study.
Key exclusion criteria (2 listed)
- Patients unwilling to complete study.
- Patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI, will be evaluated by US.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic imaging (US and MRI).Ultrasonography and MRI are performed as part of routine diagnostic evaluation, these are not therapeutic interventions | Other | Patients with superficial soft tissue masses |
Primary outcome
Diagnostic accuracy of Ultrasound and MRI in characterization of superficial soft tissue masses.
Time frame: During initial diagnostic assessment
Evaluation of the ability of ultrasound and MRI to correctly characterize superficial soft tissue masses. Diagnostic accuracy measures will include sensitivity, specificity, positive predictive value, and negative predictive value compared to the final reference diagnosis.
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 19 Dec 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy and confidentiality considerations
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.
Mohamed Hassan Alam-Eldeen, 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 Superficial Soft Tissue Masses, 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 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: opening soon, as of the sponsor's last update on 19 Dec 2025. 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?
Contact Mariam Sobhy Aziz, Resident (01212050629, mariam_sobhy_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Ultrasound and MRI in characterization of superficial soft tissue masses. (time frame: During initial diagnostic assessment). 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 19 Dec 2025.