NCT07465523

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 6, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

Breast MassDoppler UltrasoundB-Mode UltrasoundResistive Index

Outcome Measures

Primary Outcomes (1)

  • 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

    ROC curve analysis will be applied for the diagnostic performance of relative RI change in benign and malignant lesions.

    3-4 months

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince this study is a breast study, it will only be conducted on women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Hypovascular masses
  • Cystic breast masses
  • Cases with mastitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University, KEAH

Karaman, Lütfen Seçiniz., 70200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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: 10665344BACKGROUND
  • 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: 31535669BACKGROUND
  • 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: 11014252BACKGROUND

Study Officials

  • Ahmet Yeşildağ, Prof.Dr.

    Karamanoğlu Mehmetbey Universty

    STUDY DIRECTOR
  • Ahmet Yeşildağ, Prof.Dr.

    Karamanoğlu Mehmetbey University

    STUDY DIRECTOR

Central Study Contacts

Ahmet Yeşildağ, Prof.Dr

CONTACT

Gökçe Merve Arman, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

March 4, 2026

Primary Completion

May 5, 2026

Study Completion

May 19, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations