Diagnostic Accuracy of Multiparametric Dynamic Contrast Enhanced Magnetic Resonance Imaging in Improving Detection of Ultrasound Non-mass Breast Lesions According to ACR BI-RADS v2025

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorSohag University

About this trial

this study aims To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.

The study will investigate whether DCE-MRI improves lesions detected by characterization and diagnostic accuracy when interpreted according to the ACR BIRADS v 2025 and so may help optimize breast imaging evaluation and support clinical decision making

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Female patients of any age presenting with non-mass breast lesions detected on MRI or conventional imaging.

Patients who have both MRI and targeted Ultrasound examinations.

Disqualifiers

• Patients presenting with typical distinct "mass" lesions (3D space-occupying lesions) without any non-mass components.

Patients with absolute contraindications to MRI (e.g., cardiac pacemakers, severe claustrophobia, non-compatible metallic implants).

Patients with contraindications to intravenous Gadolinium contrast media (e.g., severe renal impairment/failure, pregnancy, known history of severe allergic reaction to gadolinium).

Trial population

Female patients of any age group presented with non mass lesions on either US or mammography

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • multiparametric DCE- MRI and US for all patients

    Diagnostic test

    Multiparametric DCE-MRI performed for evaluation of non mass breast lesions detected on ultrasound , with assessment of diagnostic accuracy according to ACR BIRADS v 2025

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with non mass breast lesions on US1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound

evaluation the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.

Time frame
8 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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