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Role of MRI and US in Superficial Soft Tissue Masses

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07294248
Acronym
MRI/US in SSTM
Enrollment
50
Registered
2025-12-19
Start date
2026-01-01
Completion date
2026-06-01
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial Soft Tissue Masses

Brief summary

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 \[Institutional Review Board/Ethics Committee\].

Interventions

OTHERDiagnostic imaging (US and MRI).

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of Ultrasound and MRI in characterization of superficial soft tissue masses.During initial diagnostic assessmentEvaluation 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.

Countries

Egypt

Contacts

Primary ContactMariam Sobhy Aziz, Resident
mariam_sobhy_post@med.sohag.edu.eg01212050629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026