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

NCT07554781 | Not Yet Recruiting

• 1 other identifier: SYSKY-2026-002-01
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.

  From May 2026 to May2027

Secondary Outcomes (5)

• 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

Study Arms (1)

Conventional Ultrasound and Twinkling Artifact Group

Patients examined using both B-mode ultrasound and color Doppler ultrasound (with twinkling artifact assessment).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chang Gong

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Yilin Quan

CONTACT

15191782318; quanylin@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share