Not yet recruiting NCT07679308

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

— Observational Non Mass Breast Lesions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: multiparametric DCE- MRI and US for all patients.
Who it may be relevant to: Registry conditions: Non Mass Breast Lesions. Basic parameters: No limits · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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 test multiparametric 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

Primary outcome measures

Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound [Time frame: 8 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07679308 · Soh-Med--26-6-3MD

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗