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

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dense Breast Parenchyma Breast Cancer Detection DWI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

* 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.
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Link Campus University

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role collaborator

Graziella di Grezia

OTHER

Sponsor Role lead

Responsible Party

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Graziella di Grezia

Principal Investigator

Responsibility Role SPONSOR_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

Site Status

Countries

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Italy

Other Identifiers

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T_3_2025

Identifier Type: -

Identifier Source: org_study_id

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