Mammary TumorNCT06994416
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
An observational study of Mammary Tumor and Nipple Discharge, run by The Fourth Affiliated Hospital of China Medical University at 1 site in China.
Trial summary
This retrospective cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Mammary Tumor, Nipple Discharge
- What is being tested?
- novel fluorescent localization marker needle and conventional localization marker needle
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2026
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study estimated enroll 300 patients diagnosed with intraductal breast lesion by ductoscopy at the Fourth Affiliated Hospital of China Medical University between January 2023 and December 2024. All participants met inclusion criteria, and underwent ductal excision utilizing a novel fluorescent localization marker needle or conventional localization methods.
Who may be able to join
- Female patients aged 18-75 years.
- Patients who have been diagnosed intraductal breast lesion by ductoscopy.
- Patients who have undergone ductal excision.
Who cannot join
- Pregnant or breastfeeding.
- Patients who have known allergy to quantum-dot materials or localization needle components.
- Patients with active hepatitis B or C infection with detectable viral load.
- Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).
- Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).
- Patients with incomplete clinical data.
- Patients who concurrent participation in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110032
About this study
Official title: A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study
This retrospective cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The primary goal is to evaluate the clinical effectiveness of this innovative fluorescent localization needle in facilitating accurate pathological diagnoses of micro lesions situated within breast ducts.
Read the detailed description
The diameter of breast ducts is less than 0.7 mm, which poses a considerable technical challenge in the accurate localization of early-stage small lesions during surgical and pathological sampling. These early micro lesions typically measure on the millimeter scale, necessitating an increased excision margin by surgeons to reduce the risk of overlooking them. However, this practice complicates the pathologists' ability to accurately identify these micro lesions during diagnosis, thereby heightening the likelihood of missed diagnoses and the potential for additional surgeries for patients. Current localization methods, such as liquid methylene blue and traditional localization needles, demonstrate a high rate of pathological missed diagnoses due to inaccuracies in localization and specimen contamination. Therefore, there is an urgent need for the development of innovative localization technologies that can facilitate the precise identification of millimeter-scale micro lesions within breast ducts and improve the accuracy of pathological sampling. This study aims to conduct a retrospective analysis to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating, and conventional localization techniques used during breast duct lesion surgeries. The objective is to evaluate the clinical utility of the new fluorescent localization needle in the accurate pathological diagnosis of micro lesions within breast ducts and to enhance the precision of pathological assessments.
- Conditions
- Mammary Tumor, Nipple Discharge
- Being tested
- novel fluorescent localization marker needle, conventional localization marker needle
- Keywords
- micro lesions, breast duct, fluorescent ductal needle, localization needle, controllable detachment
- Medical subject headings
- Breast Neoplasms, Galactorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel fluorescent localization marker needleDevice
novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
conventional localization marker needleDevice
conventional localization marker needle, without any coating
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation. Receives: Device: novel fluorescent localization marker needle | |
| Control | Patients received breast ductal excision surgery utilizing conventional localization methods. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation. Receives: Device: conventional localization marker needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological assessment concordance rates
Evaluate and compare the discrepancies in the consistency of intraoperative frozen and postoperative paraffin-embedded pathological assessments between subjects undergoing breast duct excision surgery utilizing a novel fluorescent localization marker needle and those employing conventional localization methods.
Measured: Data analysis period: June 2025- December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mammary TumorStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIAN WEN, The Fourth Affiliated Hospital of China Medical University
- Investigators
- Jian Wen, MD, Principal investigator, The Fourth Affiliated Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994416
- Sponsor's protocol ID
- FourthAHChinaMU
- Status last verified
- Oct 2026
- First submitted
- 20 May 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alshurbasi N, Cartlidge CWJ, Kohlhardt SR, Hadad SM. Predicting Patients Found to Have Malignancy at Nipple Duct Surgery. Breast Care (Basel). 2020 Oct;15(5):491-497. doi: 10.1159/000504528. Epub 2019 Dec 13.
PubMed 33223992
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06994416
- Acronym / sponsor ID
- FourthAHChinaMU
- Conditions
- Mammary Tumor, Nipple Discharge
- Keywords
- micro lesions, breast duct, fluorescent ductal needle, localization needle, controllable detachment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 May 2025 (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 retrospective cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The primary goal is to evaluate the clinical effectiveness of this innovative fluorescent localization needle in facilitating accurate pathological diagnoses of micro lesions situated within breast ducts.
Detailed description
The diameter of breast ducts is less than 0.7 mm, which poses a considerable technical challenge in the accurate localization of early-stage small lesions during surgical and pathological sampling. These early micro lesions typically measure on the millimeter scale, necessitating an increased excision margin by surgeons to reduce the risk of overlooking them. However, this practice complicates the pathologists' ability to accurately identify these micro lesions during diagnosis, thereby heightening the likelihood of missed diagnoses and the potential for additional surgeries for patients. Current localization methods, such as liquid methylene blue and traditional localization needles, demonstrate a high rate of pathological missed diagnoses due to inaccuracies in localization and specimen contamination. Therefore, there is an urgent need for the development of innovative localization technologies that can facilitate the precise identification of millimeter-scale micro lesions within breast ducts and improve the accuracy of pathological sampling. This study aims to conduct a retrospective analysis to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating, and conventional localization techniques used during breast duct lesion surgeries. The objective is to evaluate the clinical utility of the new fluorescent localization needle in the accurate pathological diagnosis of micro lesions within breast ducts and to enhance the precision of pathological assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Device: novel fluorescent localization marker needlePatients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation. |
| Control | – | Device: conventional localization marker needlePatients received breast ductal excision surgery utilizing conventional localization methods. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study estimated enroll 300 patients diagnosed with intraductal breast lesion by ductoscopy at the Fourth Affiliated Hospital of China Medical University between January 2023 and December 2024. All participants met inclusion criteria, and underwent ductal excision utilizing a novel fluorescent localization marker needle or conventional localization methods.
Key inclusion criteria (3 listed)
- Female patients aged 18-75 years.
- Patients who have been diagnosed intraductal breast lesion by ductoscopy.
- Patients who have undergone ductal excision.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding.
- Patients who have known allergy to quantum-dot materials or localization needle components.
- Patients with active hepatitis B or C infection with detectable viral load.
- Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).
- Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novel fluorescent localization marker needlenovel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating | Device | Experimental |
| conventional localization marker needleconventional localization marker needle, without any coating | Device | Control |
Primary outcome
pathological assessment concordance rates
Time frame: Data analysis period: June 2025- December 2025
Evaluate and compare the discrepancies in the consistency of intraoperative frozen and postoperative paraffin-embedded pathological assessments between subjects undergoing breast duct excision surgery utilizing a novel fluorescent localization marker needle and those employing conventional localization methods.
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 13 Oct 2026.
- Background: PubMed 33223992Alshurbasi N, Cartlidge CWJ, Kohlhardt SR, Hadad SM. Predicting Patients Found to Have Malignancy at Nipple Duct Surgery. Breast Care (Basel). 2020 Oct;15(5):491-497. doi: 10.1159/000504528. Epub 2019 Dec 13.
- 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. This study is not recruiting at the moment.
Jian Wen, MD principal investigator
The Fourth Affiliated Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammary Tumor and Nipple Discharge, run by The Fourth Affiliated Hospital of China Medical University at 1 site in China.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological assessment concordance rates (time frame: Data analysis period: June 2025- December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994416, which also lists 1 linked publication.
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 13 Oct 2026.