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Recruiting NCT07465523

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

Observational Breast Neoplasm Female Benign Breast Neoplasm Malign Breast Neoplasm Doppler Ultrasound Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Neoplasm Female, Benign Breast Neoplasm, Malign Breast Neoplasm, Doppler Ultrasound Diagnosis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Hypovascular masses
  • Cystic breast masses
  • Cases with mastitis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Karamanoğlu Mehmetbey University, KEAH — Karaman

Publications

  • Choi HY, Kim HY, Baek SY, Kang BC, Lee SW. Significance of resistive index in color Doppler ultrasonogram: differentiation between benign and malignant breast masses. Clin Imaging. 1999 Sep-Oct;23(5):284-8. doi: 10.1016/s0899-7071(99)00152-7. PMID 10665344
  • Niu J, Ma J, Guan X, Zhao X, Li P, Zhang M. Correlation Between Doppler Ultrasound Blood Flow Parameters and Angiogenesis and Proliferation Activity in Breast Cancer. Med Sci Monit. 2019 Sep 19;25:7035-7041. doi: 10.12659/MSM.914395. PMID 31535669
  • Mehta TS, Raza S, Baum JK. Use of Doppler ultrasound in the evaluation of breast carcinoma. Semin Ultrasound CT MR. 2000 Aug;21(4):297-307. doi: 10.1016/s0887-2171(00)90024-6. PMID 11014252

Identifiers

NCT: NCT07465523 · 26-2025/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗