Mammary TumorNCT07339306
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
A study testing novel fluorescent localization marker needle and conventional localization marker needle in people with Mammary Tumor and Nipple Discharge, run by The Fourth Affiliated Hospital of China Medical University at 1 site in China.
Trial summary
This prospective, multicenter 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… 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, Breast Ductal Carcinoma In Situ
- What is being tested?
- novel fluorescent localization marker needle and conventional localization marker needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Female patients aged 18-75 years.
- Patients scheduled to undergo duct excision surgery.
- Patients who are capable of providing written informed consent and adhering to the study protocols.
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 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 Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study
This prospective, multicenter 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 principal objective is to assess the clinical efficacy of this innovative fluorescent localization needle in enabling precise pathological diagnosis of micro lesions in breast ducts.
Read the detailed description
The diameter of breast ducts is less than 0.7 mm, presenting a significant technical challenge for the precise localization of early-stage, small lesions during surgical and pathological sampling. These early microlesions typically measure only a few millimeters, necessitating surgeons to increase excision margins to minimize the risk of overlooking them. However, this approach complicates the pathologists' ability to accurately identify these microlesions during diagnosis, thereby increasing the likelihood of missed diagnoses and the potential need for additional surgical interventions. Current localization methods, including liquid methylene blue and conventional localization needles, exhibit a high rate of pathological missed diagnoses due to localization inaccuracies and specimen contamination. Consequently, there is an urgent need to develop innovative localization technologies capable of facilitating the precise identification of millimeter-scale microlesions within breast ducts. A prospective multicenter study is required to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle-featuring a controllable shedding quantum dot chiral nanofluorescent coating-and traditional localization techniques employed in breast duct lesion surgeries. The primary objective is to evaluate the clinical efficacy of this new fluorescent localization needle in enhancing the accuracy of pathological diagnosis of microlesions within breast ducts and to improve the precision of pathological evaluations.
- 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, Carcinoma, Intraductal, Noninfiltrating
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 |
|---|---|---|
| Fluorescent Localization Group | Experimental | Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Receives: Device: novel fluorescent localization marker needle |
| Conventional Localization Group | Active comparator | Patients received breast ductal excision surgery utilizing conventional localization methods. 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: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group: Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Control Group: Patients received breast ductal excision surgery utilizing conventional localization methods.
- Masking
- None (open label)
- 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
- NCT07339306
- Sponsor's protocol ID
- FourthAHChinaMU-PMS
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 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
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 Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT07339306
- Acronym / sponsor ID
- FourthAHChinaMU-PMS
- Keywords
- micro lesions, breast duct, fluorescent ductal needle, localization needle, controllable detachment
- Study type
- Interventional
- 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 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Jan 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 prospective, multicenter 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 principal objective is to assess the clinical efficacy of this innovative fluorescent localization needle in enabling precise pathological diagnosis of micro lesions in breast ducts.
Detailed description
The diameter of breast ducts is less than 0.7 mm, presenting a significant technical challenge for the precise localization of early-stage, small lesions during surgical and pathological sampling. These early microlesions typically measure only a few millimeters, necessitating surgeons to increase excision margins to minimize the risk of overlooking them. However, this approach complicates the pathologists' ability to accurately identify these microlesions during diagnosis, thereby increasing the likelihood of missed diagnoses and the potential need for additional surgical interventions. Current localization methods, including liquid methylene blue and conventional localization needles, exhibit a high rate of pathological missed diagnoses due to localization inaccuracies and specimen contamination. Consequently, there is an urgent need to develop innovative localization technologies capable of facilitating the precise identification of millimeter-scale microlesions within breast ducts. A prospective multicenter study is required to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle-featuring a controllable shedding quantum dot chiral nanofluorescent coating-and traditional localization techniques employed in breast duct lesion surgeries. The primary objective is to evaluate the clinical efficacy of this new fluorescent localization needle in enhancing the accuracy of pathological diagnosis of microlesions within breast ducts and to improve the precision of pathological evaluations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group: Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Control Group: Patients received breast ductal excision surgery utilizing conventional localization methods.
| Arm | Type | Receives |
|---|---|---|
| Fluorescent Localization Group | Experimental | Device: novel fluorescent localization marker needlePatients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. |
| Conventional Localization Group | Active comparator | Device: conventional localization marker needlePatients received breast ductal excision surgery utilizing conventional localization methods. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 18-75 years.
- Patients scheduled to undergo duct excision surgery.
- Patients who are capable of providing written informed consent and adhering to the study protocols.
Key exclusion criteria (6 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 | Fluorescent Localization Group |
| conventional localization marker needleconventional localization marker needle, without any coating | Device | Conventional Localization Group |
Primary outcome
pathological assessment concordance rates
Time frame: From enrollment to the end of treatment at 6 weeks
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.
- 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?
A study testing novel fluorescent localization marker needle and conventional localization marker needle in people with 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 6 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: From enrollment to the end of treatment at 6 weeks). 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 13 Oct 2026.