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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07554781

Enrollment

Registered

2026-04-28

Start date

2026-05-01

Completion date

2027-05-01

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

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

Contacts

CONTACTYilin Quan

quanylin@mail2.sysu.edu.cn15191782318

STUDY_DIRECTORChang Gong

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

Outcome results