- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465523
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
Status
Recruiting
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
- Name: Ahmet Yeşildağ, Prof.Dr
- Phone Number: +905057728297
- Email: ahmetysd@hotmail.com
Study Contact Backup
- Name: Gökçe Merve Arman, Dr.
- Phone Number: +905058734762
- Email: gmerveturgut@gmail.com
Study Locations
-
-
Lütfen Seçiniz.
-
Karaman, Lütfen Seçiniz., Turkey (Türkiye), 70200
- Recruiting
- Karamanoğlu Mehmetbey University, KEAH
-
Contact:
- Ahmet Yeşildağ, Prof.Dr
- Phone Number: +905057728297
- Email: ahmetysd@hotmail.com
-
Contact:
- Gökçe Merve Yeşildağ, Dr
- Email: gmerveturgut@gmail.com
-
-
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.
General 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.
- 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.
- 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.
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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