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A simple dye might replace radioactive tracers in cancer staging

NCT ID NCT02997553

Diagnosis Sponsor: Institut de Cancérologie de Lorraine Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether indocyanine green, a dye injected before surgery, can find sentinel lymph nodes as reliably as the standard technetium-99 radioactive tracer. About 744 adults with various cancers will receive both agents, and surgeons will compare detection rates using a special probe and camera. The goal is to see if the dye alone could guide sentinel node biopsy, potentially avoiding radioactive materials.

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 (a dye) injected before surgery to help find sentinel lymph nodes, compared with the standard technetium-99 radioactive tracer.
What this could lead to
If it works, indocyanine green could replace radioactive tracers for sentinel node detection, making cancer staging safer and more accessible.
What could go wrong
The trial is early and non-inferiority is not guaranteed. The dye may not detect all nodes, and results may vary by cancer type.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

744 people

The number who actually took part.

Started

Nov 2017

Finished

Oct 2022

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: * age \>18 years * cancer histologically proved * patient eligible for sentinel node detection * contraceptive methods for men and women of childbearing age * signed informed consent form * patient affiliated to the social security system Exclusion Criteria: * neoadjuvant chemotherapy or hormone therapy * adenopathy (s) clinically suspicious or positively cytopenic * women who are pregnant or breast-feeding * associated pathology that may prevent patient of receive indocyanine green * ongoing participation in another clinical trial with an investigational drug * patients deprived of liberty or under supervision * impossibility to undergo medical follow-up of the trial for geographical, social or psychological reasons

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Conditions

The condition(s) this trial relates to.

anus cancer anus neoplasm breast carcinoma breast neoplasm cervical carcinoma endometrial cancer endometrium neoplasm head and neck cancer Head and Neck Neoplasms melanoma neoplasm ovarian cancer rectal cancer rectal neoplasm skin squamous cell carcinoma squamous cell carcinoma Uterine Cervical Neoplasms vulva cancer

As listed by the trial registrant

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

Anus cancer Breast carcinoma Cervix cancer Endometrium cancer Head and neck cancer Melanoma (skin) Ovary cancer Rectum cancer Squamous cell carcinoma (skin) Vulva cancer

Contacts and locations

Locations

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

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