NCT07339306 A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
| NCT ID | NCT07339306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Fourth Affiliated Hospital of China Medical University |
| Condition | Mammary Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2026-01-01 with a primary completion date of 2026-06-30.
⚠ 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 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.
Eligibility Criteria
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.
Contact & Investigator
Jian Wen, MD
PRINCIPAL INVESTIGATOR
The Fourth Affiliated Hospital of China Medical University
Frequently Asked Questions
Who can join the NCT07339306 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 NCT07339306 currently recruiting?
Yes, NCT07339306 is actively recruiting participants. Contact the research team at wenjian@cmu.edu.cn for enrollment information.
Where is the NCT07339306 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT07339306 clinical trial?
NCT07339306 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.