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Green dye could replace extra incisions in breast cancer surgery

NCT ID NCT07362485

Diagnosis Sponsor: Isabelle Henskens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests if a safe green dye (indocyanine green) can help surgeons find lymph nodes that might contain cancer during a mastectomy, without needing a separate cut under the arm. About 90 women with early-stage breast cancer will receive the dye and a standard radioactive tracer. The goal is to see if the dye alone can accurately identify the key lymph nodes, potentially simplifying the procedure and reducing side effects.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

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

Started

Aug 2022

Expected to finish

Jun 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.

Ages

18 years and older

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: * Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy. * Preoperative axillary ultrasound to confirm clinical node-negative status. * Indication (or preference) for mastectomy and simultaneous SLN procedure. * Written informed consent according to ICH/GCP and national regulations. Exclusion Criteria: * Patients \< 18 years old * Breast conserving surgery * Direct reconstruction (with autologous tissue or implant) * Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine * Other concurrent solid tumour * Hyperthyroidism or thyroid cancer * Pregnancy or breast feeding * Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Lymphatic Metastasis metastatic malignant neoplasm in the lymph nodes

As listed by the trial registrant

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

Breast cancer Fluorescence imaging Indocyanine green (ICG) Lymph node mapping Lymphatic metastasis Mastectomy Radioisotopes Sentinel lymph node Sentinel lymph node biopsy (SLNB) Sentinel lymph node detection

How to take part

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

  1. The places running it

    2 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

  • Isala

    RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • St. Antonius Ziekenhuis

    RECRUITING

    Utrecht, Utrecht, 3543 AZ, Netherlands

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