Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Conventional Ultrasound and Twinkling Artifact Group
- description
- Patients examined using both B-mode ultrasound and color Doppler ultrasound (with twinkling artifact assessment).
Primary outcomes (1)
- measure
- Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.
- timeFrame
- From May 2026 to May2027
Secondary outcomes (5)
- measure
- Rate of successful breast-conserving surgery.
- timeFrame
- From January 2026 to January 2027
- measure
- Re-operation rate, defined as cases with negative intraoperative margins but positive cancerous margins on final postoperative pathology.
- timeFrame
- From January 2026 to January 2027
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available