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Glowing dye could replace radioactive tracers in breast cancer surgery

NCT ID NCT07311278

Diagnosis Sponsor: St. Antonius 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a fluorescent dye called indocyanine green (ICG) can replace the current radioactive tracer (technetium) for finding sentinel lymph nodes in breast cancer patients. About 493 women with early-stage breast cancer will take part. Surgeons will first use the standard method, then learn to use ICG, comparing how well each method finds the lymph nodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indocyanine green (ICG) dye
What this could lead to
If successful, this could make sentinel lymph node detection safer and more accessible by replacing radioactive tracers with a fluorescent dye.
What could go wrong
This is an implementation study, not a test of effectiveness. ICG may not work as well as technetium in all patients, and results may vary across hospitals.

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 493 people

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

Started

Jun 2023

Expected to finish

Oct 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

Anyone

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 or invasive breast cancer confirmed by biopsy * Preoperative axillary ultrasound to confirm clinical node-negative status * Indication for breast cancer surgery with SLNB via axillar incision * Written informed consent according to ICH/GCP and national regulations. Exclusion Criteria: * Patients \< 18 years old. * Indication for breast cancer surgery with SLNB via mastectomy incision * Combined MARI procedure * Known allergy for Indocyanine Green (ICG) or intravenous contrast or iodine * History of axillary lymph node dissection * 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

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, Netherlands

  • Bernhoven Ziekenhuis

    Uden, Netherlands

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • FlevoZiekenhuis

    Almere Stad, Netherlands

  • HagaZiekenhuis

    The Hague, Netherlands

  • Isala Ziekenhuis

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Maastricht Universitair Medisch Centrum

    Maastricht, Netherlands

  • Ospedale Pederzoli

    Peschiera del Garda, Italy

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Van Weel-Bethesda Ziekenhuis

    Dirksland, Netherlands

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