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Glow-in-the-Dark dye could replace radioactive tracer in breast cancer surgery

NCT ID NCT07441733

Knowledge-focused Sponsor: Casa di Cura Dott. Pederzoli 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a fluorescent dye called indocyanine green (ICG) can effectively identify sentinel lymph nodes in breast cancer patients, potentially replacing the standard radioactive tracer. Forty women with early-stage breast cancer will receive both methods, and doctors will compare how often each finds the nodes. If ICG works as well, it could simplify the procedure and avoid radioactivity.

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)
What this could lead to
If successful, this could replace the standard radioactive tracer with a safer, more accessible dye for sentinel lymph node biopsy in breast cancer.
What could go wrong
This is a small pilot study (40 participants) at a single hospital, so results may not apply broadly. ICG may not identify nodes as reliably as the current method.

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 40 people

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

Started

Nov 2024

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

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 or invasive stage T1-T3 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 national regulations Exclusion Criteria: * Patients \< 18 years old. * Indication for breast cancer surgery with SLNB via mastectomy incision * Known allergy for ICG, intravenous contrast or iodine * History of axillary lymph node dissection * 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

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

  • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

    RECRUITING

    Peschiera del Garda, Verona, Italy

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