DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue

N/AEnrolling By InvitationNCT06836089

Graziella di Grezia350 enrolled

Overview

his clinical trial aims to evaluate the efficacy and diagnostic accuracy of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. DWI is investigated as an adjunctive method to improve early tumor detection in women with dense breasts, a group at high risk for delayed diagnosis due to limited visibility in mammography. Study Purpose: To assess the utility of Diffusion Weighted Imaging (DWI) in improving diagnostic accuracy for patients with dense breasts.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Dense Breast Parenchyma Breast Cancer Detection DWI

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 40-75 years. * Patients with dense breast tissue, classified according to BI-RADS (Breast Imaging-Reporting and Data System). * Patients who previously underwent breast MRI, including Diffusion Weighted Imaging (DWI). * Availability of histopathological confirmation for breast lesions (biopsy results). Exclusion Criteria: * Patients with a known allergy to gadolinium-based contrast agents. * Pregnant or breastfeeding women at the time of imaging. * Presence of metallic implants or other MRI-incompatible devices. * Patients with incomplete imaging datasets (e.g., missing DWI sequences or non-standardized protocols). * Prior history of breast cancer treatment (surgery, chemotherapy, or radiotherapy) before the imaging study.

Outcomes

Primary Outcomes

Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study

This retrospective cohort study aims to assess the diagnostic accuracy and clinical utility of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. By analyzing previously collected imaging data, the study evaluates the sensitivity, specificity, and predictive value of DWI in detecting malignant breast lesions. The research also examines the correlation between Apparent Diffusion Coefficient (ADC) values and histopathological tumor characteristics, comparing DWI's performance with conventional MRI and mammography/tomosynthesis.

Time frame: 12 months