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

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.

Sex

All

Minimum age

18 Years

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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