Clinical trial NCT06836089: DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue
Official title: DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dense Breast Parenchyma
Breast Cancer Detection
DWI
Keywords: Breast MRI
DWI
dense breast
Lead sponsor: Link Campus University
Sponsor class: OTHER
Collaborators: name: Link Campus University
name: University of Campania Luigi Vanvitelli
First posted: 2025-02-20
Enrollment: 350
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
affiliation: Link Campus University
name: Graziella Di Grezia, medicine and surgery
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Gianluca Gatta, medicine and surgery
role: STUDY_CHAIR
References: