Status:
NOT_YET_RECRUITING
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
Lead Sponsor:
The Fourth Affiliated Hospital of China Medical University
Conditions:
Mammary Tumor
Nipple Discharge
Eligibility:
FEMALE
18-75 years
Brief 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 w...
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. Th...
Eligibility Criteria
Inclusion
- Female patients aged 18-75 years.
- Patients who have been diagnosed intraductal breast lesion by ductoscopy.
- Patients who have undergone ductal excision.
- Patients who are capable of providing written informed consent and adhering to the study protocols.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06994416
Start Date
June 1 2025
End Date
May 31 2026
Last Update
June 4 2025
Active Locations (1)
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1
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110032