A Single-Center, Retrospective Study to Improve the Visibility of Breast Tissue Marker Clips in Breast Tissue and Axillary Lymph Nodes Using the Color Doppler Twinkling Artifact

A Single-Center, Retrospective Study on Enhancing the Visibility of Breast Tissue Marker Clips in Breast Tissue and Axillary Lymph Nodes Using the Twinkling Artifact Feature in Color Doppler Ultrasound

This single-center, retrospective study aims to evaluate the utility of the color Doppler twinkling artifact feature in improving the visibility of breast tissue marker clips within breast tissue and axillary lymph nodes. The study population will consist of approximately 86 female patients (with 110 clips) who have undergone placement of breast tissue marker clips and have corresponding preoperative imaging data from GE-10 or Siemens ultrasound systems between October 2024 and October 2025. The primary endpoint is the proportion of subjects whose implanted clips exhibit the characteristic "twinkling artifact" on color Doppler ultrasound imaging, reported with a 95% confidence interval.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 86

Contacts and Locations

• Study Contact: Name: Yilin Quan; Phone Number: 15191782318; Email: quanylin@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People who have had a breast tissue marker clip placed in their breast or underarm area.

Description

Inclusion Criteria:

• Female patients aged ≥18 years.
• Presence of suspicious breast lesions confirmed by ultrasound.
• Successful implantation of a breast tissue marker clip with accurate radiological documentation.
• Availability of preoperative breast ultrasound examinations (including B-mode and Color Doppler) performed using either a GE-10 or Siemens ultrasound system.
• Confirmation of clip placement via mammography, surgical specimen morphology, or same-day post-implantation ultrasound.

Exclusion Criteria:

• Pregnancy or lactation.
• History of ipsilateral breast malignancy or surgery.
• Presence of other metal implants potentially interfering with imaging.
• Suspicious mammographic microcalcifications in the target lesion.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Conventional Ultrasound and Twinkling Artifact Group; Patients examined using both B-mode ultrasound and color Doppler ultrasound (with twinkling artifact assessment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.	From May 2026 to May2027

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of successful breast-conserving surgery.	From January 2026 to January 2027
Re-operation rate, defined as cases with negative intraoperative margins but positive cancerous margins on final postoperative pathology.	From January 2026 to January 2027
Inter-observer agreement rate in interpreting B-mode ultrasound visibility and Twinkling Artifact results among different radiologists.	From January 2026 to January 2027
Proportion of subjects in whom the marker clip appears as a "hyperechoic structure" on conventional B-mode ultrasound.	From January 2026 to January 2027
Positive margin rate.	From January 2026 to January 2027

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSKY-2026-002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No