Role of MRI and US in Superficial Soft Tissue Masses (MRI/US in SSTM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Superficial Soft Tissue Masses
• Intervention / Treatment: Other: Diagnostic imaging (US and MRI).

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Mariam Sobhy Aziz, Resident; Phone Number: 01212050629; Email: mariam_sobhy_post@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt
      • Sohag University Hospital
      • Contact: Mariam Sobhy Aziz, Resident; Phone Number: 01212050629; Email: mariam_sobhy_post@med.sohag.edu.eg
      • Contact: Email: mariam_sobhy_post@med.sohag.edu.eg
      • Principal Investigator: Mariam Sobhy Aziz, Resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Patients who suffer from superficial soft tissue lesions in both sex and of any age group, will be included in the study.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with superficial soft tissue masses; Participants diagnosed with superficial soft tissue masses undergoing ultrasound and MRI for diagnostic characterization.	Other: Diagnostic imaging (US and MRI).; Ultrasonography and MRI are performed as part of routine diagnostic evaluation, these are not therapeutic interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During initial diagnostic assessment

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Mohamed Hassan Alam-Eldeen, MD

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Physical Phenomena; Chemistry Techniques, Analytical; Spectrum Analysis; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Magnetic Resonance Spectroscopy; X-Rays
• Other Study ID Numbers: Soh-Med--25-11-15MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to privacy and confidentiality considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No