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Glow-in-the-Dark dye could help surgeons spot brain tumors

NCT ID NCT07438860

Diagnosis Sponsor: Tiffany Hodges 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a fluorescent dye called SBK2-ICG in 12 adults with untreated malignant brain tumors. The dye is given before surgery to see if it can make tumor edges glow, helping surgeons remove as much tumor as possible while protecting healthy brain. The main goal is to check safety, with a secondary goal of seeing how well it works compared to an existing method.

What this could mean

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

Active substance
SBK2-ICG (a fluorescent dye)
What this could lead to
If successful, this could help surgeons see tumor boundaries more clearly during brain surgery, potentially leading to more complete tumor removal while sparing healthy brain tissue.
What could go wrong
This is a very early Phase 1 safety study with only 12 participants. The dye may not work as hoped, or side effects could limit its use. It is not yet approved by the FDA.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: * Participants must have suspected or confirmed untreated malignant brain tumors * Participants must have received no prior therapies for this disease. * Participants are 18 years of age or older. Because no dosing or adverse event data are currently available on the use of SBK2-ICG in individuals under 18 years of age, children are excluded from this study. * Karnofsky Performance status ≥ 60% * Glioma is located in the supratentorial region of the brain. * Tumor is suitable for resection on the basis of imaging studies and participant and surgeon must plan resection * Able and willing to undergo MRI scan. * Participants must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Pregnant individuals or those who are breast feeding. * Individuals with AST, ALT, ALP, or bilirubin \>2.5x normal upper limit any time during the previous 2 months. * Individuals with plasma creatinine \> 2.5 mg/dL. * Individuals without a probable or expected grade IV glioma. * Individuals not planning surgery on glioma. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG or other agents used in this study. * Note: A baseline blood sample will be drawn for creatinine, AST, ALT, ALP, and bilirubin to verify whether or not this exclusion criterion is met.

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Conditions

The condition(s) this trial relates to.

brain cancer glioma

As listed by the trial registrant

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

GLIOMA Malignant brain tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • Premier Health Neuroscience Institute

    Dayton, Ohio, 45409, United States

  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106, United States

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