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

NCT06836089 | Enrolling By Invitation

• 1 other identifier: T_3_2025
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Dense Breast Parenchyma; Breast Cancer Detection; DWI

Keywords

Breast MRI; DWI; dense breast

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Group of women with dense breast

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Graziella di Grezia: lead
• Link Campus University: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

Location

Study Officials

• Graziella Di Grezia, medicine and surgery

  Link Campus University

  PRINCIPAL INVESTIGATOR

• Gianluca Gatta, medicine and surgery

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: January 1, 2025
• Primary Completion: February 1, 2025
• Study Completion: January 31, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)