Clinical trial · Observational
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study
- 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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mammary Tumor | — | UNRESOLVED | — |
| Nipple Discharge | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional localization marker needle | Device | — | UNRESOLVED |
| novel fluorescent localization marker needle | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental
- description
- 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.
- interventionNames
- Device: novel fluorescent localization marker needle
- label
- Control
- description
- 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.
- interventionNames
- Device: conventional localization marker needle
Primary outcomes (1)
- measure
- pathological assessment concordance rates
- timeFrame
- Data analysis period: June 2025- December 2025
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged 18-75 years. 2. Patients who have been diagnosed intraductal breast lesion by ductoscopy. 3. Patients who have undergone ductal excision. Exclusion Criteria: 1. Pregnant or breastfeeding. 2. Patients who have known allergy to quantum-dot materials or localization needle components. 3. Patients with active hepatitis B or C infection with detectable viral load. 4. Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure). 5. Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia). 6. Patients with incomplete clinical data. 7. Patients who concurrent participation in another interventional clinical trial.
References
Publications (1)
- BACKGROUNDAlshurbasi 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. PMID 33223992