DWI Breast MRI in Dense Breast: A Clinical Trial to Asses... | NCT06836089

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Feb 1, 2025Actual

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Feb 15, 2025

First Submission Date that Met QC Criteria

Feb 15, 2025

First Posted Date

Feb 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2025

Last Update Posted Date

Feb 20, 2025Actual

Name	Class
Link Campus University	OTHER
University of Campania Luigi Vanvitelli	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Label	Type	Description	Intervention Names
Group of women with dense breast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study	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.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Graziella Di Grezia, medicine and surgery	Link Campus University	Principal Investigator
Gianluca Gatta, medicine and surgery	University of Campania Luigi Vanvitelli	Study Chair