SBK2-ICG for Brain Cancer

Not yet recruiting at 1 trial location
TH
Overseen ByTiffany Hodges, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Tiffany Hodges
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new drug, SBK2-ICG, to help surgeons better visualize the edges of brain tumors during surgery. By clearly identifying the tumor's borders, doctors aim to remove as much of the tumor as possible while protecting healthy brain tissue. The trial seeks participants with a suspected or confirmed brain tumor that hasn't been treated yet and who plan to have it surgically removed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must not have received any prior therapies for their brain tumor, it's possible that you may need to stop certain treatments. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that SBK2-ICG is likely to be safe for humans?

Research has shown that SBK2-ICG, a drug used to highlight brain tumors, has been tested in earlier studies. In animal tests, the drug successfully highlighted tumors and defined their edges within 30 minutes. This is crucial because it can help surgeons remove tumors more completely while protecting healthy brain tissue.

Regarding safety, the drug remains in the early stages of human testing. Researchers are closely studying how the body processes it and any potential side effects. So far, there is limited information about side effects in humans. However, similar studies with indocyanine green (ICG), the main component of SBK2-ICG, have shown it is generally well-tolerated in other medical uses.

Since this study is in the initial phase, the main goal is to find the right dose and ensure safety. Participants will receive a single dose of SBK2-ICG before their surgery. Those considering joining should note that the safety profile is still being fully explored and documented.12345

Why do researchers think this study treatment might be promising for brain cancer?

Unlike the standard treatments for brain cancer, which typically involve surgery, radiation, and chemotherapy, SBK2-ICG is unique because it integrates a novel imaging technique using fluorescence. Researchers are excited about this treatment because it uses a special dye, SBK2-ICG, that makes brain tumors glow under specific lighting during surgery, allowing surgeons to see the tumor more clearly and potentially remove it more completely. This method could significantly enhance surgical precision, leading to better outcomes and fewer complications for patients.

What evidence suggests that SBK2-ICG is effective for detecting brain tumor margins?

Research has shown that SBK2-ICG, the investigational treatment in this trial, helps surgeons see the edges of brain tumors more clearly during surgery. Studies have found that ICG, a component of SBK2-ICG, makes tumors visible in just 30 minutes, aiding in identifying the tumor's borders. In tests with rats, it guided the removal of brain tumors. Additionally, SBK2-ICG highlighted brain tumors more effectively than some other imaging agents. This suggests that SBK2-ICG could help surgeons remove as much of the tumor as possible while avoiding healthy brain tissue.12367

Who Is on the Research Team?

TH

Tiffany Hodges, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with a suspected or confirmed malignant brain tumor in the upper part of the brain, who have not had prior treatment and are planning to have surgery to remove the tumor. Participants must be able to undergo an MRI and sign consent.

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.
See 5 more

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

Trial Overview

The study tests SBK2-ICG, an experimental imaging drug given before standard brain tumor surgery (craniotomy), to see if it helps surgeons better see the edges of tumors during removal. The main goal is finding the best dose for clear imaging.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SBK2-ICG-Guided Fluorescence Imaging of Brain TumorsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tiffany Hodges

Lead Sponsor

Citations

A Safety Study Using SBK2-ICG | NCT07438860

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.

Comparison of Near-Infrared Imaging Agents Targeting ...

SBK2-ICG showed significantly higher in vivo tumor labeling compared to the Scram-ICG control from 10 min to 24 h, p < 0.01 at all timepoints, following ...

Focused Ultrasound with Chemotherapy

Results were published in the journal Lancet Oncology and show that trial participants had nearly 14 months of median progression-free survival, ...

SBK2-ICG for Brain Cancer · Info for Participants

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 ...

Fluorescent guided surgical resection of glioma using targeted ...

ICG highlights tumors within 30 minutes, and can identify tumor margins and guide surgical resection in rat glioma models. In patients with different types of ...

Fluorescence-Guided Imaging of Brain Tumors

Publications for the trial NCT07438860.

NCT03262636 | Two-Part Study to Evaluate the Safety and ...

The first objective is to determine safety/efficacy of high dose, delayed indocyanine green (second window ICG) during surgery of nervous system tumors.