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Glowing dye could help surgeons spot hidden brain tumor cells

NCT ID NCT07233954

Knowledge-focused Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is testing whether a dye called sodium fluorescein can help surgeons better see and remove aggressive brain tumors during surgery. The dye is injected into the bloodstream and collects in tumors where the blood-brain barrier is broken, making them glow under a special microscope. Researchers will enroll about 100 patients with suspected CNS tumors to see how well the dye works and if it leads to more complete tumor removal.

What this could mean

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

Active substance
sodium fluorescein
What this could lead to
If successful, this could help surgeons remove more tumor tissue during brain surgery, potentially improving survival and quality of life for patients with aggressive CNS tumors.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove the dye improves outcomes. Results may not apply to all patients, and there is a small risk of allergic reactions to the dye.

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.

Participants

About 100 people

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

Started

Jan 2016

Expected to finish

Dec 2027

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.

Who is studied

Patients of both genders, at any age.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients of both genders, at any age. 2. Patients with suspected aggressive lesion of the CNS, as suggested by pre-operative MRI or CT with i.v. contrast agent administration. Exclusion Criteria: 1. Impossibility to give consent due to cognitive deficits or language disorder. 2. Known allergy to contrast agents and/or history of previous anaphylactic shocks. 3. Known severe previous adverse reactions to Fluorescein 4. Acute myocardial infarction or stroke in the last 90 days. 5. Severe renal failure; 6. Severe hepatic failure; 7. Women in their first trimester of pregnancy or lactation.

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Conditions

The condition(s) this trial relates to.

central nervous system cancer central nervous system disorder Margins of Excision neoplasm

As listed by the trial registrant

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

CNS

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

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, Italy

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