Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2026-01-01
2026-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with superficial soft tissue masses
Participants diagnosed with superficial soft tissue masses undergoing ultrasound and MRI for diagnostic characterization.
Diagnostic imaging (US and MRI).
Ultrasonography and MRI are performed as part of routine diagnostic evaluation, these are not therapeutic interventions
Interventions
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Diagnostic imaging (US and MRI).
Ultrasonography and MRI are performed as part of routine diagnostic evaluation, these are not therapeutic interventions
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with absolute or relative contraindications for imaging including; claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI, will be evaluated by US.
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Mariam Sobhy Aziz
Resident
Principal Investigators
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Mohamed Hassan Alam-Eldeen, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Sohag University Hospital
Sohag, Sohag Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Mariam Sobhy Aziz, Resident
Role: primary
Role: backup
Other Identifiers
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Soh-Med--25-11-15MS
Identifier Type: -
Identifier Source: org_study_id