DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dense Breast Parenchyma, Breast Cancer Detection, DWI. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- University of Campania Luigi Vanvitelli — Naples
Identifiers
NCT: NCT06836089 · T_3_2025