FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma

This clinical trial aims to determine if FG001 can assist surgeons in identifying the difference between tumor and healthy tissue during surgery in participants with newly diagnosed high-grade glioma. The scheduled neurosurgical tumor resection will occur under NIR fluorescence guidance and support the surgeons in achieving complete removal of the cancer. FG001 is a 'fluorescent imaging agent,' which is a dye that glows under a special light to help doctors see certain tissues. The main questions it aims to answer are: 1. To see how well a special light (called NIR fluorescence imaging) can show the difference between the tumor and the nearby healthy tissue during surgery. This difference is measured by comparing how bright the tumor looks to how bright the normal tissue looks. 2. Another goal is to find out how many patients have almost all the tumor removed. This is checked by looking at MRI scans, taken within 48 hours after surgery, to see if the leftover tumor is smaller than 0.175 cubic centimeters. Participants will receive FG001 before tumor resection surgery and will participate in follow-up visits during the six months after surgery. Follow-up visits may include brain MRI, bloodwork, physical assessments, vital signs, assessment of functional and neurologic status, quality-of-life assessments, adverse event monitoring, and review of concomitant medications.

NCT Number	NCT07609472
Lead Sponsor	FluoGuide A/S
Conditions	High-Grade Glioma (WHO III-IV)
Enrollment	76 participants
Start Date	2026-06-30
Primary Completion	2028-07-31 (estimated)
Study Completion	2028-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-29