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

Conditions

• Glioma
• Malignant Brain Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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).
• 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.

Study Details

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.

Key Dates

Start date

Mar 2, 2026

Status verified

Feb 2026

Primary completion

Nov 1, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• 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.

Primary Outcome Measure

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) ]

Central Contacts

• Tiffany Hodges, MD
  (216) 844-2724
  [email protected]

Locations (2)

Find similar trials in Cleveland, OH

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