NCT06994416 A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
| NCT ID | NCT06994416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Fourth Affiliated Hospital of China Medical University |
| Condition | Mammary Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Jian Wen, MD
PRINCIPAL INVESTIGATOR
The Fourth Affiliated Hospital of China Medical University
Frequently Asked Questions
Who can join the NCT06994416 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Mammary Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06994416 currently recruiting?
Yes, NCT06994416 is actively recruiting participants. Contact the research team at wenjian@cmu.edu.cn for enrollment information.
Where is the NCT06994416 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06994416 clinical trial?
NCT06994416 is sponsored by The Fourth Affiliated Hospital of China Medical University. The principal investigator is Jian Wen, MD at The Fourth Affiliated Hospital of China Medical University. The trial plans to enroll 300 participants.