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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 主要终点
- Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Conventional Ultrasound and Twinkling Artifact Group
Patients examined using both B-mode ultrasound and color Doppler ultrasound (with twinkling artifact assessment).
结局指标
主要结局
Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.
时间窗: From May 2026 to May2027
次要结局
- 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)
- 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)
研究者
Chang Gong
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University