Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07554781

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: From May 2026 to May2027

Secondary outcomes

  1. Rate of successful breast-conserving surgery.

    Time frame: From January 2026 to January 2027

  2. Re-operation rate, defined as cases with negative intraoperative margins but positive cancerous margins on final postoperative pathology.

    Time frame: From January 2026 to January 2027

  3. Inter-observer agreement rate in interpreting B-mode ultrasound visibility and Twinkling Artifact results among different radiologists.

    Time frame: From January 2026 to January 2027

  4. Proportion of subjects in whom the marker clip appears as a "hyperechoic structure" on conventional B-mode ultrasound.

    Time frame: From January 2026 to January 2027

  5. Positive margin rate.

    Time frame: From January 2026 to January 2027

Study contacts

Contact information is provided by the study sponsor or research team.

Yilin Quan

CONTACT

[email protected]

15191782318

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.