FG001 for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a substance called FG001, which helps surgeons see brain cancer more clearly during surgery. It uses a special light to make the cancer glow, aiding doctors in distinguishing it from healthy brain tissue. The goal is to remove more of the tumor and leave less behind. This trial targets individuals recently diagnosed with high-grade glioma, an aggressive brain cancer, who have not yet received any treatment. Participants will receive FG001 before surgery and attend follow-up visits for six months to monitor their recovery and health. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this fluorescent imaging agent is safe for use in brain cancer surgery?
Research has shown that FG001 is generally safe and well-tolerated. An earlier study with 35 brain cancer patients found FG001 to be safe, with only two mild, non-serious side effects reported. These results align with researchers' expectations, suggesting the treatment is manageable for most patients. This makes FG001 a promising option for those considering participation in clinical trials.12345
Why are researchers excited about this trial's treatment for brain cancer?
Researchers are excited about FG001 because it offers a new way to visualize brain cancer during surgery. Unlike traditional treatments that rely on imaging before surgery, FG001 is an optical imaging agent used during the operation itself. It helps surgeons see malignant tissue in real-time with near-infrared fluorescence, potentially improving the precision of tumor removal. This innovative approach could lead to better outcomes and fewer complications for patients undergoing brain cancer surgery.
What evidence suggests that FG001 is effective for identifying brain cancer during surgery?
Research has shown that FG001, which participants in this trial will receive, can help brain surgeons distinguish between tumors and healthy tissue during operations. In a study with 35 patients, FG001 was administered before surgery and made the tumor stand out clearly from normal brain tissue. This dye highlighted cancerous areas, making it easier for surgeons to identify what to remove. Another study found that FG001 successfully highlighted tumors in all patients, suggesting it could improve tumor detection. Although more data is needed, these early results suggest FG001 might help surgeons remove more of the tumor safely.678910
Who Is on the Research Team?
Robert Bilkovski, MD, MBA, Chief Medical Officer
Principal Investigator
FluoGuide A/S
Are You a Good Fit for This Trial?
This trial is for people with newly diagnosed high-grade glioma (a type of aggressive brain tumor) who are scheduled to have surgery to remove the tumor. Participants must be able to undergo surgery and follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative
Pre-operative MRI and assessments, including pre-dose anti-drug antibody sampling and administration of FG001
Surgical
Neurosurgical tumor resection supported by NIR fluorescence imaging with FG001
Post-operative
Post-operative assessments including MRI, laboratory assessments, and adverse event monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI, quality-of-life assessments, and adverse event monitoring
What Are the Treatments Tested in This Trial?
Interventions
- FG001
Trial Overview
The study tests FG001, a dye that makes tumors glow under special light during brain surgery. This helps surgeons better see and remove cancerous tissue while sparing healthy brain tissue. Patients get FG001 before their operation.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
FG001 is an investigational optical imaging agent administered as a single dose prior to neurosurgery to support intraoperative visualization of malignant tissue under near-infrared fluorescence guidance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
FluoGuide A/S
Lead Sponsor
Citations
1.
cancernetwork.com
cancernetwork.com/view/fda-grants-fast-track-designation-to-fg001-for-high-grade-glioma-surgeryFDA Grants Fast Track Designation to FG001 for High- ...
FG001 remain limited, and no peer-reviewed efficacy or safety results have yet been published. outcomes remain poor and recurrence is nearly ...
Intraoperative Imaging and Optical Visualization Techniques ...
Advancements in intraoperative visualization and imaging techniques are increasingly central to the success and safety of brain tumor surgery, ...
3.
journals.lww.com
journals.lww.com/neurosurgery/fulltext/2025/12000/novel_urokinase_type_plasminogen_activator.21.aspxFirst-in-Human Study in 35 Patients with Brain Cancer
RESULTS: Administration of FG001 at a dose of 36 mg, 12 to 17 hours before surgery, resulted in optimal image contrast between tumor and normal brain tissue ...
FG001 – Application in Therapy and Current Clinical ...
FG001 (also known as ICG-Glu-Glu-AE105) is an investigational optical imaging agent designed to help neurosurgeons better visualize brain tumors during surgery.
Positive interim results from an investigator-initiated study ...
FG001 is both effective and well tolerated in several phase II clinical trials. The lead indications of FG001 are aggressive brain cancer
6.
cancernetwork.com
cancernetwork.com/view/fda-clears-ind-for-phase-2-registration-trial-of-fg001-in-high-grade-gliomaFDA Clears IND for Phase 2 Registration Trial of FG001 in ...
FG001 is an optical imaging agent engineered to assist surgeons in the real-time visualization of cancer cells during surgical procedures, a ...
First-in-Human Study in 35 Patients with Brain Cancer
FG001 was found to be safe and well tolerated in the patients included in the study. The optimal dose of FG001 was selected on the basis of videos taken ...
FG001 Meets Detection End Point in High-Grade Glioma
Findings also showed that FG001 was well tolerated. Two grade 1 adverse effects were reported. “These results are in line with our expectations ...
FG001 in Subjects with Meningiomas or Presumed Low- ...
The efficacy of FG001 as a tumor imaging agent and safety will be monitored. The efficacy is examined by the sensitivity and specificity. Sensitivity is ...
10.
clinicaltrials.eu
clinicaltrials.eu/trial/study-of-fg001-for-detecting-meningioma-or-low-grade-glioma-in-patients-undergoing-neurosurgery/Study of FG001 for Detecting Meningioma or Low-Grade ...
The trial aims to provide valuable information on the use of FG001 in helping surgeons identify and remove Meningioma and Glioma tumors more accurately. This ...
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