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

Graziella di Grezia

Status: Invitation-only

Conditions: Dense Breast Parenchyma; Breast Cancer Detection; DWI

Study type: Observational

Funder types: Other

Identifiers

NCT06836089

T_3_2025

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 1 patient group

Group of women with dense breast