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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06836089

Acronym

DWI-Breast MRI

Enrollment

350

Registered

2025-02-20

Start date

2025-01-01

Completion date

2026-01-31

Last updated

2025-02-20

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

Conditions

Breast Cancer Detection, Dense Breast Parenchyma, DWI

Keywords

Breast MRI, DWI, dense breast

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study	12 months	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.

Countries

Italy

Outcome results