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Fluorescence-Guided Imaging of Brain Tumors Using SBK2-ICG

This study is for people with suspected or confirmed malignant brain tumors who need surgery. The goal is to see if a drug called SBK2-ICG can help surgeons better see the edges of brain tumors during surgery. This could allow for more complete tumor removal while protecting healthy brain tissue. You would receive a single intravenous (IV) dose of SBK2-ICG about an hour before your scheduled brain surgery (craniotomy). Researchers will then use special light during your surgery to see how SBK2-ICG highlights the tumor. The main goal is to check the safety of SBK2-ICG by tracking any side effects you might experience.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is not specified if it is randomized, blinded, or what phase it is.
What's involved
You would receive one IV dose of SBK2-ICG an hour before your craniotomy. You would then undergo standard brain surgery.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 14 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07438860

Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2-ICG

Not Yet Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Tiffany Hodges
~12 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:SBK2-ICGCraniotomy (Standard of Care)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs)
Measured over Up to 14 days after surgery (Day 14)

Conditions

Malignant Brain Tumors
Glioma

Explore related trials

Glioma

Where it's being run

2 sites across 1 states
Ohio2

Study leadership

  • Tiffany Hodges, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Who to contact

Tiffany Hodges, MD
[email protected]
(216) 844-2724
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs)Up to 14 days after surgery (Day 14)

    Safety will be measured by prevalence of AEs, defined according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 criteria.