Clinical trial · Interventional
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter 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 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| 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)
- type
- EXPERIMENTAL
- label
- Fluorescent Localization Group
- description
- Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle.
- interventionNames
- Device: novel fluorescent localization marker needle
- type
- ACTIVE_COMPARATOR
- label
- Conventional Localization Group
- description
- Patients received breast ductal excision surgery utilizing conventional localization methods.
- interventionNames
- Device: conventional localization marker needle
Primary outcomes (1)
- measure
- pathological assessment concordance rates
- timeFrame
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 scheduled to undergo duct excision surgery. 3. Patients who are capable of providing written informed consent and adhering to the study protocols. 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 who concurrent participation in another interventional clinical trial.
References
Publications (0)
Data not yet available