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NCT Number: NCT07294248

Role of MRI and US in 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic imaging (US and MRI).

Other

Ultrasonography and MRI are performed as part of routine diagnostic evaluation, these are not therapeutic interventions

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Sobhy Aziz, Resident

CONTACT

[email protected]

01212050629

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Diagnostic Role of Magnetic Resonance Imaging and Ultrasonography in Characterization of Superficial Soft Tissue Masses.

Acronym: MRI/US in SSTM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.