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Can a single tracer light up cancer's first stop? a trial puts a hybrid dye-and-radioactive marker to the test.

NCT ID NCT06666634

Diagnosis Sponsor: The Netherlands Cancer Institute 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests whether a new hybrid tracer, ICG-99mTc-nanoscan, can replace the standard tracer for sentinel node biopsy in people with penile cancer, melanoma, or oral cancer. The hybrid tracer combines a fluorescent dye with a radioactive marker, potentially allowing surgeons to see lymph nodes both before and during surgery with one injection. Researchers will compare how well the new tracer matches the standard one in identifying sentinel nodes on imaging. The study enrolls 29 adults scheduled for a sentinel node procedure as part of their routine care.

What this could mean

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

Active substance
a hybrid tracer called ICG-99mTc-nanoscan, combining a fluorescent dye and a radioactive marker to help surgeons locate sentinel lymph nodes
What this could lead to
If the new tracer proves as effective as the standard one, it could simplify sentinel node procedures by allowing both preoperative imaging and real-time surgical guidance with a single injection.
What could go wrong
This is a small validation study with only 29 participants, so results may not apply broadly. The new tracer might not match the standard's accuracy, and there is a risk of allergic reaction or false negatives.

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

29 people

The number who actually took part.

Started

Apr 2023

Finished

Jul 2025

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: * Patient who will undergo a sentinel node procedure in routine care. * Patients \> 18 years; * Patients presenting with: * a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities; * OR patients presenting with a primary oral cavity malignancy T1-2N0 * OR patients with primary penile cancer * Patients with clinical N0 stage; * Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion; * Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting Exclusion Criteria: * Patients with known allergy to patent blue dye or nanocolloid; * Patients who are pregnant or breast-feeding mothers; * History of hypersensitivity reactions to products containing human serum albumin; * History of iodine allergy * Hyperthyroid or thyroidal adenoma * Kidney insufficiency * Incapacity or unwillingness of participant to give written informed consent;

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma lip and oral cavity carcinoma melanoma Mouth Neoplasms oral cavity cancer penile cancer penile neoplasm

As listed by the trial registrant

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

Melanoma Oral cancer Penile cancer

Contacts and locations

Locations

  • NKI-AVL

    Amsterdam, Netherlands

More trials for these conditions

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