The University of Texas Medical Branch (UTMB) will enroll its first patient in a U.S. Phase 2 clinical trial evaluating a new imaging agent designed to help neurosurgeons better visualize brain tumors during surgery.
The multicenter trial is studying FG001, an investigational imaging agent developed by Denmark-based biotechnology company FluoGuide A/S for patients with newly diagnosed high-grade glioma, classified by the World Health Organization as grade 3 or grade 4 tumors.
Gliomas are aggressive brain tumors that can be particularly difficult to remove completely.
Pablo Valdes, MD, PhD, FAANS, director of Neurosurgical Oncology at UTMB, is leading the study.
The U.S. Food and Drug Administration recently granted Fast Track designation to FG001, recognizing its potential to address an unmet need in the treatment of high-grade glioma.
“High-grade glioma is a devastating disease, and surgeons need better tools to identify and remove cancerous tissue while preserving healthy brain tissue,” Valdes said. “FG001 has the potential to improve intraoperative tumor detection, and I am excited to evaluate this new imaging agent to support more precise surgery for patients with high-grade glioma.”
Making cancer easier to see
One of the challenges of brain tumor surgery is determining exactly where a tumor ends and healthy brain tissue begins.
FG001 is designed to make that distinction easier to see in real time.
Patients participating in the trial receive a single intravenous dose of FG001 approximately 12 to 19 hours before surgery. The agent is designed to bind to cancerous tissue. During the operation, surgeons use specialized near-infrared imaging equipment that causes tissue containing FG001 to fluoresce, or light up.
The technology is intended to provide surgeons with a visual guide to help identify cancerous tissue during surgery.
That distinction is particularly important in brain surgery. Removing more tumor tissue may benefit patients, but surgeons must also avoid damaging healthy brain tissue responsible for critical functions.
The Phase 2 study will evaluate how well FG001 distinguishes tumor tissue from surrounding tissue and whether it can help guide the surgical removal of high-grade gliomas. Researchers will also use MRI scans performed within 48 hours after surgery to assess how much of the tumor was removed.
Participants will be followed for six months after surgery. Researchers will monitor safety, neurological function, the ability to perform everyday activities, and quality of life.
Advancing fluorescence-guided brain surgery
Valdes is a nationally recognized neurosurgeon and bioengineer whose research focuses on developing technologies to improve brain tumor surgery. His work includes fluorescence-guided surgery, brain mapping, and biomedical optics, the use of light-based technologies in medicine.
FG001 fits directly into that area of research by providing surgeons with information that may be difficult to obtain with the naked eye alone.
The U.S. Food and Drug Administration has authorized the Phase 2 clinical trial through its Investigational New Drug process and granted FG001 Fast Track designation as an imaging agent in patients with suspected high-grade-glioma.
Fast Track designation is intended to help speed the development and review of treatments and other medical products for serious conditions when there is an unmet medical need. It does not mean FG001 has been approved by the FDA.
The trial is prospective, multicenter, and open-label, meaning it is being conducted at multiple medical centers and both researchers and participants know that FG001 is being administered.
Researchers are evaluating a dose of 0.45 milligrams per kilogram of body weight. Among the study’s key measures will be how clearly tumor tissue fluoresces compared with surrounding tissue, how much tumor remains after surgery, and whether findings seen with fluorescence correspond with laboratory analysis of tissue removed during surgery.
FG001 is FluoGuide’s most advanced investigational imaging agent. In addition to high-grade glioma, the company is studying the technology for use in other cancers, including oral cancer and other head and neck cancers.
For Valdes, the goal is ultimately straightforward.
“Ultimately, this is about giving patients the best possible outcome. The more clearly we can distinguish tumor from healthy brain during surgery, the better equipped we are to remove the tumor safely and precisely. Our hope is that advanced tools will provide that critical information when surgeons need it most.”