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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07679308

Enrollment

Registered

2026-07-01

Start date

2026-06-01

Completion date

2028-01-01

Last updated

2026-07-01

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

Conditions

Non Mass Breast Lesions

Keywords

DCE Breast MRI, Non mass breast lesions, Breast US

Brief summary

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

Detailed description

* Background: Non-mass breast lesions detected by ultrasound may present diagnostic challenges because of their variable imaging appearances and overlap between benign and malignant findings. * Objective: 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 according to ACR BIRADS v 2025. * Methods: This observational study will include patients with non-mass breast lesions identified on breast ultrasound or mammography. Participants will undergo breast MRI examination including dynamic contrast-enhanced sequences. Imaging findings will be assessed according to ACR BI-RADS 2025 criteria . * Outcome Measures: The primary outcome will be the diagnostic performance of DCE-MRI, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy in differentiating benign from malignant lesions. * Significance: The study aims to determine whether multiparametric DCE-MRI can improve characterization of ultrasound-detected non-mass breast lesions and support more accurate clinical decision-making.

Interventions

DIAGNOSTIC_TESTmultiparametric DCE- MRI and US for all patients

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* • 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.

Exclusion criteria

* • 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).

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound	8 months	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.

Contacts

CONTACTAlaa Nor Abdelghafar Nor Abdelghafar, Assistant Lecturer

alaa011053@med.sohag.edu.eg01063550892

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026