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Glowing needle could spot tiny breast tumors during surgery

NCT ID NCT06994416

Diagnosis Sponsor: The Fourth Affiliated Hospital of China Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a new needle that glows under special light to help surgeons find and sample very small, high-risk breast lesions during surgery. The goal is to see if this method gives more accurate and faster results compared to standard techniques. The study involves 300 women aged 18-75 who have breast duct lesions and need surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This retrospective study estimated enroll 300 patients diagnosed with intraductal breast lesion by ductoscopy at the Fourth Affiliated Hospital of China Medical University between January 2023 and December 2024. All participants met inclusion criteria, and underwent ductal excision utilizing a novel fluorescent localization marker needle or conventional localization methods.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm galactorrhea intraductal breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mammary tumor Nipple discharge

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Fourth Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110032, China

More trials for these conditions

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