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NCT Number: 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

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

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Key information

Sex eligibility

Female

Study type

Observational

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Nor Abdelghafar Nor Abdelghafar, Assistant Lecturer

CONTACT

[email protected]

01063550892

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.