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Official title A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts

ClinicalTrials.gov ID: NCT07339306

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75, women only

You may be able to join if

  • Female patients aged 18-75 years.
  • Patients scheduled to undergo duct excision surgery.
  • Patients who are capable of providing written informed consent and adhering to the study protocols.

You likely can't join if

  • 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 treatment clinical trial.

The study team makes the final eligibility decision.

Where it's taking place

  • Shenyang, Liaoning, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.