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

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.

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Key information

Conditions

Dense Breast Parenchyma Breast Cancer Detection DWI

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Graziella di Grezia

Other

Collaborators

Link Campus University
University of Campania Luigi Vanvitelli

Registry information

Acronym: DWI-Breast MRI

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Feb 20, 2025
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed