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.
Age 18 and older
Radiological evidence of a unifocal, contrast-enhancing brain lesion consistent with HGG, characterized by ring-enhancing or heterogeneously enhancing tumor with central hypointensity suggestive of necrosis, based on preoperative contrast-enhanced T1-weighted MRI.
Glioblastoma, IDH-wildtype (CNS WHO Grade 4)
Astrocytoma, IDH-mutant (CNS WHO Grade 3 or 4)
Tumor location in the midline, basal ganglia, cerebellum, or brainstem where resection is not safely achievable or is considered high-risk.
Tumors judged by the PI to infiltrate critical motor pathways.
Single group
FG001
DrugFG001 is an investigational optical imaging agent administered as a single intravenous dose prior to neurosurgical tumor resection to support intraoperative visualization of malignant tissue under near-infrared fluorescence guidance.
Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal Tissue
Performance of a single dose of FG001 0.45 mg/kg administered 12 to 19 hours before surgery will be assessed using the tumor-to-background ratio of near-infrared fluorescence imaging of tumor bulk in situ and adjacent normal tissue under direct visualization. Tumor-to-background ratio will be calculated as the mean fluorescence intensity in the tumor region of interest divided by the mean fluorescence intensity in the background region of interest.
Proportion of Patients Achieving Gross Total Resection Based on Volumetric Analysis of Contrast-Enhanced MRI
Gross total resection will be defined as less than 0.175 cm³ residual contrast-enhancing tumor, as determined by volumetric analysis of contrast-enhanced MRI performed within 48 hours postoperatively.
Proportion of Subjects Achieving RANO Resect Class 1 Based on Early Postoperative MRI
RANO Resect Class 1, also referred to as supramaximal contrast-enhancing resection, will be assessed using early postoperative MRI. RANO Resect Class 1 is defined as complete contrast-enhancing tumor resection, with no measurable residual contrast-enhancing tumor volume, and residual non-contrast-enhancing T2/FLAIR volume of 5.0 cm³ or less.
Proportion of Subjects Achieving Response Assessment in Neuro-Oncology Resect Class 2 Based on Early Postoperative MRI
Response Assessment in Neuro-Oncology Resect Class 2, defined as complete or near-total resection of contrast-enhancing tumor, will be assessed using early postoperative MRI following fluorescence-guided surgery. Class 2A is defined as complete contrast-enhancing tumor resection with no measurable residual contrast-enhancing tumor volume and greater than 5 cm³ of non-contrast-enhancing tumor resection. Class 2B is defined as near-total contrast-enhancing tumor resection with residual contrast-enhancing tumor volume of 1.0 cm³ or less. Results for Class 2A and Class 2B will be summarized separately and in aggregate.
Proportion of Subjects Classified as Response Assessment in Neuro-Oncology Resect Class 3 Based on Early Postoperative MRI
Response Assessment in Neuro-Oncology Resect Class 3, also referred to as submaximal contrast-enhancing resection, will be assessed using early postoperative MRI. Class 3 is defined as measurable residual contrast-enhancing tumor volume greater than 1.0 cm³. Class 3A is defined as residual contrast-enhancing tumor volume of 5.0 cm³ or less, and Class 3B is defined as residual contrast-enhancing tumor volume greater than 5.0 cm³. Results for Class 3A and Class 3B will be summarized separately.
Proportion of Subjects With Progression-Free Survival at 3 Months Based on Clinical Evaluation and MRI Assessment Using Response Assessment in Neuro-Oncology Criteria
Progression-free survival at 3 months is defined as the proportion of subjects who remain alive and free from radiographic or clinical progression 3 months after surgical resection. Progression status will be determined by clinical evaluation and MRI assessment using Response Assessment in Neuro-Oncology criteria.
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