DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue
NCT ID: NCT06836089
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
350 participants
OBSERVATIONAL
2025-01-01
2026-01-31
Brief Summary
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Study Purpose:
To assess the utility of Diffusion Weighted Imaging (DWI) in improving diagnostic accuracy for patients with dense breasts.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Group of women with dense breast
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
FEMALE
No
Sponsors
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Link Campus University
OTHER
University of Campania Luigi Vanvitelli
OTHER
Graziella di Grezia
OTHER
Responsible Party
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Graziella di Grezia
Principal Investigator
Principal Investigators
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Graziella Di Grezia, medicine and surgery
Role: PRINCIPAL_INVESTIGATOR
Link Campus University
Gianluca Gatta, medicine and surgery
Role: STUDY_CHAIR
University of Campania Luigi Vanvitelli
Locations
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University of Campania Luigi Vanvitelli
Naples, , Italy
Countries
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Other Identifiers
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T_3_2025
Identifier Type: -
Identifier Source: org_study_id
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