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

February 23, 2026 updated by: Tiffany Hodges

Fluorescence-Guided Imaging of Brain Tumors: A Safety Study Using SBK2- ICG in a Phase 1 Clinical Trial

Participants in this research study are people who are likely to have, or have been diagnosed with a brain tumor, for which surgical removal (or "resection") is the standard of care treatment. The purpose of this study is to see whether a drug called SBK2-ICG can be used to locate the true outline or "edges" of the tumor. If the tumor outline could be accurately identified at the time of surgery, the fullest extent of tumor could be removed while sparing the normal brain tissue.

Participants will receive SBK2-ICG about an hour before they receive surgery. The extent of surgery to be performed will not be changed in this study. Researchers will only use the information from the study to determine the best SBK2-ICG dose for accurate tumor margin (i.e., the border or edges of the tumor with the normal brain) detection so that no tumor is left behind.

The use of SBK2-ICG in brain tumors is experimental, which means that the U.S. Food and Drug Administration (FDA) has not approved it for use to locate brain tumors. However, the use of the drug SBK2-ICG for the purposes of this study is on file with the FDA.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Treating people with serious brain tumors is challenging, and the outlook for these people is poor. On average, people survive less than one year after their are diagnosed. How long someone lives after diagnosis and treatment may depend on how much of the tumor is able to be removed with surgery. However, it can be difficult for surgeons to tell the difference between where the tumor is and where healthy brain tissue is using standard white light surgical microscope illumination. Because of this, new methods to help surgeons see tumor borders more clearly during surgery could be valuable.

Fluorescence imaging may be one method that can help surgeons see tumor borders more clearly. Previous studies have used fluorescence imaging to better visualize tumors, but no previous studies have used SBK2-ICG. In fact, the use of SBK2-ICG is conceptually different than other studies.

Currently, the only FDA approved drug used in fluorescent imaging for visualizing brain tumors during surgery is called 5-aminolevulinic acid, or 5-ALA. 5-ALA is naturally metabolized in human cells to something called PpIX. When people are given 5-ALA before surgery, it gets turned into PpIX, which can then be excited by fluorescent light at wavelengths of 400-410 nm. Because tumor cells and healthy cells metabolize 5-ALA in different ways, PpIX tends to accumulate in epithelial and malignant cells, including brain tumor cells. In a review of previous studies, using 5-ALA was associated with better removal of tumor tissue, longer overall survival, and longer progression-free survival. However, 5-ALA only weakly detects tumor borders and does not identify infiltrative cells on the edges of tumors. Also, even thin barriers of normal cells can make it difficult for surgeons to see 5-ALA, which makes it difficult to tell the difference between tumor tissue and healthy tissue. Because of this, it would be helpful to use a drug that emits a light that more deeply penetrates brain tissue so that surgeons can see tumor tissue and healthy tissue better.

SBK2-ICG is different than 5-ALA because it is not metabolized by the human body. Instead, SBK2-ICG attaches to a unique piece of cells that accumulates in tumors. SBK2-ICG can also be excited at a wavelength of 789 nm, rather than the wavelength of 400-410 nm that 5-ALA is excited at. SBK2-ICG gives off a near infrared light when it is excited, making it easier to see the borders of tumors. It also helps with seeing deep inside of the tumor. Using SBK2-ICG and fluorescent light has been shown to identify more than 99% of tumor cells in rodent xenograft models of human brain tumors in the lab.

Researchers want to assess the safety of SBK2-ICG in people with brain tumors who are already planning to have surgery to remove their tumor and see how SBK2-ICG compares to standard practices in identifying tumor tissue versus healthy tissue.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
        • Principal Investigator:
          • Tiffany Hodges, MD
        • Contact:
          • Tiffany Hodges, MD
      • Dayton, Ohio, United States, 45409
        • Premier Health Neuroscience Institute
        • Contact:
          • Andrew Sloan, MD, FACS
        • Principal Investigator:
          • Andrew Sloan, MD, FACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors
Participants will receive study drug SBK2-ICG one hour prior to their standard of care craniotomy (brain surgery), where fluorescence images will be take in addition to white light (standard of care) images.
Drug: SBK2-ICG
Participants will receive a single intravenous (IV) dose of SBK2-ICG one hour prior to their craniotomy (brain surgery). The starting dose is 0.072 mg/kg. The dose may be adjusted based on participants experiencing adverse events or based on participant response and fluorescence detection. If the 0.072mg/kg dose is well tolerated, researchers will examine fluorescence. If there are no Grade II or higher adverse events and researchers observe good fluorescence that is specific, researchers will continue to use that dose. If there is no fluorescence and the dose is well tolerated, researchers will increase the dose 0.216mg/kg. If there is too much background fluorescence, researchers can drop to a lower dose (0.072 mg/kg or 0.024 mg/kg).
Procedure: Craniotomy (Standard of Care)
Participants will undergo a craniotomy (brain surgery) per standard of care. During the surgery, the study drug SBK2-ICG (given one hour prior to the surgery) and fluorescence light will be used to visualize the brain tumor(s). White light images (the standard of care) will also be used to visualize the tumor(s). The surgeon will take tissue biopsies based on standard of care processes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs)
Time Frame: 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.
Up to 14 days after surgery (Day 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the imaging agent SBK2-ICG relative to 5-ALA
Time Frame: Day of surgery (Day 1)
Diagnostic performance will be measured on the basis of a visual score of the imaging agent's ability to detect high-grade invasive glioma tumor in comparison to histopathological samples and/or standard white light from surgical microscope at the variable dose levels.
Day of surgery (Day 1)
Clinical usefulness of the imaging agent SBK2-ICG for eventual fluorescence-guided resection, as measured by percent tumor present
Time Frame: Day of surgery (Day 1)
The tumor present in the biopsy specimens will be compared to the percentage of tumor identified via the imaging agent SBK2-ICG at the dose levels tested.
Day of surgery (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tiffany Hodges

Investigators

  • Principal Investigator: Tiffany Hodges, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE8325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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