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)

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 Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer Detection; Dense Breast Parenchyma; DWI

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80138
    • University of Campania Luigi Vanvitelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will analyze a retrospective cohort of women aged 40-75 years with dense breast tissue, classified according to BI-RADS criteria. The population consists of patients who previously underwent breast MRI with Diffusion Weighted Imaging (DWI) as part of their clinical evaluation for breast cancer screening or diagnostic workup.

The dataset includes cases from multiple imaging centers, ensuring variability in patient demographics and imaging protocols. The study population will encompass:

Women with dense breasts, a group at higher risk for missed diagnoses due to the limitations of mammography.

Patients with both benign and malignant breast lesions, confirmed through histopathology (biopsy results).

Cases where mammography, tomosynthesis, and conventional MRI were performed, allowing for a comparative diagnostic accuracy assessment.

Patients with prior breast cancer treatment, missing imaging sequences, or MRI-incompatible conditions will be excluded to maintain data consiste

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Group of women with dense breast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Graziella di Grezia
• Collaborators: Link Campus University; University of Campania Luigi Vanvitelli
• Investigators: Principal Investigator: Graziella Di Grezia, Medicine and Surgery, Link Campus University; Study Chair: Gianluca Gatta, medicine and surgery, University of Campania Luigi Vanvitelli

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): February 1, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: DWI; dense breast; Breast MRI
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: T_3_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No