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New scanner could slash repeat breast surgeries

NCT ID NCT07311317

Diagnosis Sponsor: West China Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new handheld scanner that gives surgeons a real-time, close-up view of the surgical area to see if any cancer cells remain after removing a breast tumor. Current methods can take time and may miss some cancer cells, sometimes requiring a second surgery. The scanner aims to be faster and more accurate, potentially helping 165 women with early-stage breast cancer avoid additional operations.

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 165 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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 study will enroll 165 adult female patients scheduled to undergo breast surgery for histologically confirmed breast cancer. Eligible participants must provide written informed consent.

Ages

18 to 70 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: * Age between 18 - 70 years * Patients scheduled for breast tumor resection * Clinically or radiologically showing a solitary lesion and 1. (Before neoadjuvant chemotherapy) Maximum tumor diameter ≤ 5cm; 2. cN0-1; 3. No clinical or imaging evidence of nipple, skin, chest wall invasion, or distant metastasis before surgery. * Subjects voluntarily sign informed consent or are exempted from signing upon approval by the ethics committee. Exclusion Criteria: * Inflammatory breast cancer; * Patients allergic to methylene blue and sodium fluorescein; * Unable to understand the trial requirements or unable to complete the study follow-up plan; * Pregnant and breastfeeding women; * Patients unable to complete follow-up due to mental illness, cognitive or emotional disorders; * Those with severe comorbidities (such as organ dysfunction, immune deficiency) or poor general condition; * Those participating in other clinical studies that may affect this trial; * Those for whom satisfactory specimens for both frozen pathology and paraffin pathology cannot be obtained during surgery; * Those who cannot obtain a paraffin pathology report.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer early stage breast cancer (stage 1-3)

How to take part

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

  1. The places running it

    3 sites. 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

  • West China Fourth Hospital, Sichuan University

    Chengdu, China

  • West China Hospital

    Chengdu, China

  • the Fourth People'S Hospital of Sichuan Province

    Chengdu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.