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Clinical Trials in Italy / NCT06836089
Enrolling by invitation Observational

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 · tracked via the Priya Life Science Italy tracker
Sponsor
Graziella di Grezia
Phase
Observational
Started
2025-01-01
Last updated
2025-02-20

Condition(s) studied

Dense Breast ParenchymaBreast Cancer DetectionDWI

Study 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

Sex
FEMALE
Min age
40 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
University of Campania Luigi Vanvitelli Naples Italy

More Graziella di Grezia trials in Italy

From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System Enrolling by invitation
Contrast Enhanced Mammography or Breast Magnetic Resonance: Which Choice for Optimal Diagnostic Performance? Enrolling by invitation
Contrast Enhanced Mammography in the Evaluation of Cancer of Unknown Primary Syndrome Enrolling by invitation
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization Enrolling by invitation

Other trials for the same condition

Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06836089 on ClinicalTrials.gov ↗ ← All trials in Italy