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

Sohag University

Status

Not yet enrolling

Conditions

Superficial Soft Tissue Masses

Treatments

Other: Diagnostic imaging (US and MRI).

Study type

Observational

Funder types

Other

Identifiers

NCT07294248

Soh-Med--25-11-15MS

Details and patient eligibility

About

The goal of this observational study to evaluate the accuracy of Magnetic Resonance Imaging and Ultrasonography in characterization of superficial soft tissue masses.

Full 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].

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.