A Novel Approach in the Evaluation of Breast Masses With Doppler US

March 12, 2026 updated by: Ahmet Yesildag

A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation

In cases with breast masses, Doppler resistive index values will be calculated for the mass and surrounding healthy tissue and the opposite healthy breast tissue, and their effect on distinguishing between benign and malignant masses will be evaluated.

Study Overview

Detailed Description

The aim of this study is to reveal the role of differences in the resistive index of masses and surrounding tissue in distinguishing between benign and malignant masses using a new approach in the evaluation of breast masses with Doppler ultrasound. The minimum, maximum, and average RI values obtained from the mass and healthy breast tissue will be recorded. The relative RI value difference will be calculated from the RI values of the mass and healthy tissue. Based on the pathology results, the cases will be divided into two groups: benign and malignant. The threshold values of these values in malignant and benign masses will be determined and compared. Additionally, vascular index values in breast masses will be calculated and compared using the relatively new Doppler Microvascular Flow method.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Lütfen Seçiniz.
      • Karaman, Lütfen Seçiniz., Turkey (Türkiye), 70200
        • Recruiting
        • Karamanoğlu Mehmetbey University, KEAH
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of female patients over the age of 18 who underwent breast biopsy in the radiology department due to a solid lesion in the breast.

Description

Inclusion Criteria:

  • Those with solid breast masses
  • Female patients
  • Those with pathology results

Exclusion Criteria:

  • Hypovascular masses
  • Cystic breast masses
  • Cases with mastitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation
Time Frame: 3-4 months
ROC curve analysis will be applied for the diagnostic performance of relative RI change in benign and malignant lesions.
3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Ahmet Yeşildağ, Prof.Dr., Karamanoglu Mehmetbey Universty
  • Study Director: Ahmet Yeşildağ, Prof.Dr., Karamanoglu Mehmetbey University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

May 19, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-2025/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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