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

NCT07438860 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CASE8325
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Malignant Brain Tumors; Glioma

Keywords

SBK2-ICG

Outcome Measures

Primary Outcomes (1)

• Safety of the imaging agent SBK2-ICG, as measured by prevalence of adverse events (AEs)

  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 Outcomes (2)

• Diagnostic performance of the imaging agent SBK2-ICG relative to 5-ALA

  Day of surgery (Day 1)

• Clinical usefulness of the imaging agent SBK2-ICG for eventual fluorescence-guided resection, as measured by percent tumor present

  Day of surgery (Day 1)

Study Arms (1)

SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors

EXPERIMENTAL

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; Procedure: Craniotomy (Standard of Care)

Interventions

SBK2-ICG DRUG

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).

SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors

Craniotomy (Standard of Care) PROCEDURE

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.

SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tiffany Hodges: lead

Study Sites (2)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Premier Health Neuroscience Institute

Dayton, Ohio, 45409, United States

Location

Related Publications (14)

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  PMID: 8930102 BACKGROUND

• Stummer W, Reulen HJ, Meinel T, Pichlmeier U, Schumacher W, Tonn JC, Rohde V, Oppel F, Turowski B, Woiciechowsky C, Franz K, Pietsch T; ALA-Glioma Study Group. Extent of resection and survival in glioblastoma multiforme: identification of and adjustment for bias. Neurosurgery. 2008 Mar;62(3):564-76; discussion 564-76. doi: 10.1227/01.neu.0000317304.31579.17.

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• Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.

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  PMID: 20376568 BACKGROUND

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MeSH Terms

Conditions

Glioma

Interventions

Craniotomy; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tiffany Hodges, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Hodges, MD

CONTACT

(216) 844-2724; Tiffany.Hodges@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)