SBK2-ICG for Brain Cancer

Not yet recruiting at 1 trial location

Overseen By Tiffany Hodges, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Tiffany Hodges

Disqualifiers: Pregnancy, Liver dysfunction, Kidney dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Tiffany Hodges, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not received any treatment for this disease.

I am 18 years old or older.

I can care for myself and do some normal activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Participants receive SBK2-ICG about an hour before surgery for fluorescence-guided imaging

1 hour

1 visit (in-person)

Surgery and Imaging

Standard of care craniotomy is performed with additional fluorescence imaging using SBK2-ICG

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of SBK2-ICG after surgery

Up to 14 days

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SBK2-ICG

How Is the Trial Designed?

Group I: SBK2-ICG-Guided Fluorescence Imaging of Brain Tumors Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Tiffany Hodges

Lead Sponsor