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Testing a dye that may show the edges of a brain tumor during surgery

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

The short version

Doctors are testing a dye that may help them see where a brain tumor ends.

Read our full plain-language summary

What the trial team says

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 facts

Registry number

NCT07438860

Stage of testing

Phase 1

Conditions studied

Malignant Brain Tumors, Glioma

Where it is running

This trial lists 2 sites.

• Ohio
  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center (Cleveland)
  • Premier Health Neuroscience Institute (Dayton)

This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.