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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

86 Participants
are grouped into 1 trial group
Group A: Conventional Ultrasound and Twinkling Artifact Group

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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