Breast CancerNCT07554781
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
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: People who have had a breast tissue marker clip placed in their breast or underarm area.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ultrasound and Twinkling Artifact Group | Patients examined using both B-mode ultrasound and color Doppler ultrasound (with twinkling artifact assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.
Measured: From May 2026 to May2027
Secondary outcomes (5)
Rate of successful breast-conserving surgery.
Measured: From January 2026 to January 2027
Re-operation rate, defined as cases with negative intraoperative margins but positive cancerous margins on final postoperative pathology.
Measured: From January 2026 to January 2027
Inter-observer agreement rate in interpreting B-mode ultrasound visibility and Twinkling Artifact results among different radiologists.
Measured: From January 2026 to January 2027
Proportion of subjects in whom the marker clip appears as a "hyperechoic structure" on conventional B-mode ultrasound.
Measured: From January 2026 to January 2027
Positive margin rate.
Measured: From January 2026 to January 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Chang Gong, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554781
- Sponsor's protocol ID
- SYSKY-2026-002-01
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07554781
- Acronym / sponsor ID
- SYSKY-2026-002-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional Ultrasound and Twinkling Artifact Group | – | –Patients examined using both B-mode ultrasound and color Doppler ultrasound (with twinkling artifact assessment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have had a breast tissue marker clip placed in their breast or underarm area.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound.
Time frame: From May 2026 to May2027
5 secondary outcomes
Rate of successful breast-conserving surgery.
Time frame: From January 2026 to January 2027
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
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
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
Positive margin rate.
Time frame: From January 2026 to January 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chang Gong study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilin Quan (15191782318, quanylin@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects exhibiting the "Twinkling Artifact" posterior to the marker clip on Color Doppler Ultrasound. (time frame: From May 2026 to May2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.