A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts (NCT07339306) | Clinical Trial Compass
RecruitingNot Applicable
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
China300 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new fluorescent needle to find and sample tiny lesions inside breast ducts — how does this compare to the standard biopsy or ductoscopy approach my care team would normally use to investigate my nipple discharge or suspected DCIS?
2Since this trial is measuring how well the fluorescent needle's samples match the actual pathology results, what happens if the sample taken during the trial turns out to be inconclusive — would I still need a standard biopsy afterward?
3This study is listed as 'Phase NA,' which suggests it's more of a device feasibility or diagnostic accuracy study rather than a treatment trial — does that mean my actual treatment plan wouldn't change based on my participation, and I'd still receive standard care?
4What are the risks specific to having this fluorescent ductal needle used in my breast duct, and are there any concerns about the fluorescent dye or the needle itself that I should know about before deciding?
5Given that my situation involves a possible mammary tumor or ductal carcinoma in situ, would it be better for me to pursue standard diagnosis and treatment first before considering participation in a device-testing study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pathological assessment concordance rates
Timeframe: From enrollment to the end of treatment at 6 weeks
Trial details
NCT IDNCT07339306
SponsorThe Fourth Affiliated Hospital of China Medical University