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

Prospective, Single Group, Open-label Multicenter Phase 2 Study With Single-dose Administration of the Optical Imaging Agent FG001 in Subjects With Newly Diagnosed High Grade Glioma Scheduled for Neurosurgical Tumor Resection Under NIR Fluorescence Guidance

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High-Grade Glioma (WHO III-IV)
• Intervention / Treatment: Drug: FG001

Detailed Description

INVESTIGATIONAL PLAN This is a prospective, multicenter, Phase 2 dose confirmation study of FG001 (0.45 mg/kg) with diagnostic purpose (optimal imaging agent) and a single group under NIR fluorescence imaging with FG001. Dosage will be 0.45 mg/kg FG001, single dose, intravenous injection, 12 to 19 hours before surgery. Neurosurgical tumor resection will be supported by NIR fluorescence imaging with FG001. Evaluation of MR imaging and histopathology will be conducted by central neuroradiologists and neuropathologists, respectively.

Overall Design The overall trial design is an open-label assessment of FG001 to confirm the acceptability of the dose selected (0.45 mg/kg administered within 12-19 hours of surgery).

Trial Schedule

Eligible subjects will undergo the following sequence of events:

• Screening (to be completed ≤30 days before surgery)
• Pre-operative MRI (obtained within 48 hours) prior to surgery
• Pretreatment (conducted in accordance with local institution practice)
• Pre-dose Anti-drug antibody (ADA) sampling
• Administration of FG001 12-19 hours prior to surgery
• Pre-operative assessments (1 hour and 3-12 hours following IP administration)

• Neurosurgical intervention with planned study assessments

  • Surgical Phase I: Dura View
  • Surgical Phase II: Cortex View
  • Surgical Phase III: Tumor View
  • Surgical Phase IV: Tumor Margin View
  • Surgical Phase V: Tumor Cavity View

• Postoperative Assessments

  • Day 0 (±12 hours): Laboratory assessments, tumor characterization labs (including IDH and MGMT), and adverse events
  • Within 48 hours: MRI
  • Over 72 hours post-operative: collection of FG001 urine excretion metabolites
• Over 48 hours post-operative: PK analysis
• Day 3 (±12 hours): physical exam, vital signs, NANO scale, ECG and AEs
• Post-operative Assessments:
• Day 7 (±1 day): physical examination, safety assessments, Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, serum chemistries and hematology, anti-drug antibody sampling, ECG, adverse event monitoring, and concomitant medication review.
• Week 6 (±1 week): follow-up assessments, including Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, quality-of-life assessment, adverse event monitoring, concomitant medication review, steroid use documentation, temozolomide compliance, and anti-drug antibody sampling.
• 3 Months (±2 weeks): follow-up assessments, including MRI, Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, quality-of-life assessment, adverse event monitoring, concomitant medication review, temozolomide compliance, steroid use documentation, and disease progression and survival assessment.
• 6 Months (±2 weeks): final follow-up assessments, including physical examination, vital signs, MRI, Karnofsky Performance Status, Neurologic Assessment in Neuro-Oncology Scale, neurocognitive assessment, quality-of-life assessment, adverse event monitoring, concomitant medication review, temozolomide compliance, steroid use documentation, and disease progression and survival assessment, as applicable.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Donna Haire, Chief Operating Officer; Phone Number: 4404790511; Email: dh@fluoguide.com
• Study Contact Backup: Name: Christopher Bruce, Director, Clinical Operations; Phone Number: +45 30167903; Email: cb@fluoguide.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami
      • Contact: Michael Ivan, M.D.; Phone Number: 973-563-4755; Email: mivan@med.miami.edu
      • Contact: Roxane Mayrand; Phone Number: 786-348-7211; Email: r.mayrand@umiami.edu
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03567
      • Dartmouth Hitchcock Medical Center
      • Contact: Linton Evans, M.D.; Phone Number: (603) 650-5109; Email: Linton.T.Evans@Hitchcock.org
      • Contact: Nathan Simmons, M.D.; Phone Number: (603) 650-5109; Email: Nathan.E.Simmons@Hitchcock.org
      • Principal Investigator: Linton Evans, M.D.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital
      • Contact: Constantinos G. Hadjipanayis, M.D.; Phone Number: 412-647-6781; Email: hadjipanayiscg2@upmc.edu
      • Contact: Kristy Boggs; Phone Number: 412-647-8952; Email: boggskd@upmc.edu
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
      • Contact: Pablo A Valdes, M.D.; Phone Number: 603 410 7225; Email: paavalde@utmb.edu
      • Contact: Chisom Onwunyi; Phone Number: 409 266 0247; Email: chonwuny@UTMB.EDU
      • Principal Investigator: Pablo Valdes, M.D.
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute, University of Utah
      • Contact: Randy Jensen, M.D.; Phone Number: 801 585 0617; Email: randy.jensen@hsc.utah.edu
      • Contact: Rachel Kingsford; Phone Number: 801 585 0115; Email: rachel.kingsford@hci.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 and older
2. 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.

3. Suspected HGG based on imaging, later confirmed as WHO Grade 3 or 4 glioma postsurgery. Eligible histologies (WHO CNS5) upon intraoperative or postoperative confirmation are:

   • Glioblastoma, IDH-wildtype (CNS WHO Grade 4)
   • Astrocytoma, IDH-mutant (CNS WHO Grade 3 or 4)
   • Oligodendroglioma, IDH-mutant, 1p/19q-codeleted (CNS WHO Grade 3)
   • Ependymoma (CNS WHO Grade 3)
4. No prior tumor-specific treatment, including surgery, chemotherapy, radiotherapy, or investigational therapy (i.e., newly diagnosed, treatment-naïve HGG).
5. Subject is scheduled to undergo first neurosurgical intervention with the intent of GTR of the contrast-enhancing lesion.
6. Surgery must be clinically anticipated to allow GTR, defined as removal of ≥98% of contrast-enhancing tumor, based on neurosurgeon assessment and preoperative imaging.
7. Indication for surgical tumor resection. The anatomical location of the contrast agent-accumulating tumor allows the possibility of complete resection. Resectability and EOR will be retrospectively assessed by an independent blinded centralized review of preoperative and postoperative MRI.
8. KPS ≥70, as assessed within 14 days prior to study treatment. Subject must not previously have received the trial drug (FG001).
9. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit and avoid sperm donation during this period.
10. Women of childbearing potential must agree to use highly effective method of contraception during the trial and for 30 days after the end-of-trial visit. Acceptable methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhea; may be confirmed with FSH test if there is doubt).
11. Subject is capable of understanding and giving written informed consent

Exclusion Criteria:

1. Tumor location in the midline, basal ganglia, cerebellum, or brainstem where resection is not safely achievable or is considered high-risk.
2. Tumors judged by the PI to infiltrate critical motor pathways.
3. Multifocal disease, defined as:

3a. More than one contrast-enhancing lesion; or 3b. Additional contrast-enhancing lesions unrelated to the primary tumor; or 3c. Evidence of extracerebral metastases

4. Substantial non-contrast-enhancing tumor areas suggestive of low-grade glioma with malignant transformation, as assessed by preoperative MRI. Defined as ≥50% of non-CE volume in relation to CE tumor volume.

5. Tumor location is not amenable to GTR based on neuro-surgeon assessment.

6. Application of iMRI or intraoperative ultrasound guidance during surgical resection is prohibited to avoid bias in resection outcome measurement.

7. Medical contraindications to MRI (e.g., pacemaker).

8. Any known allergy or hypersensitivity to: 8a. ICG or any component of the IP 8b. Gadolinium-based contrast agents

9. Pre-existing severe chronic renal impairment, defined as: 9a. Estimated indexed and non-indexed glomerular filtration rate (eGFR ≤30 mL/min/1.73 m² AND (eGFR ≤30 mL/min) 9b. Assessed within 30 days prior to enrollment

10. Pre-existing hepatic insufficiency, defined as: 10a. AST and alanine transaminase ALT >3 times the upper limit of normal; or 10b. Total bilirubin >1.5 times the upper limit of normal unless the elevation is attributable to Gilbert's syndrome.

10c. Assessed within 30 days prior to enrollment

11. Abnormal coagulation profile, defined as any: 11a. Platelets < 100,000 11b. aPTT >1.5x upper limit of normal, or 11c. INR > 1.7 11d. Assessed within 30 days prior to enrollment

12. QTc will be assessed using Fridericia's correction (QTcF); thresholds for exclusion is > 470 ms or subjects with QTcF > 470 ms will be excluded.

13. History of malignant tumor in any body site (excluding adequately treated basal cell carcinoma of the skin).

14. Unwilling or unable to follow the protocol requirements.

15. Prior history of serious gastrointestinal perforation, diverticulitis, and/or peptic ulcer disease.

16. Existing or planned pregnancy or lactation, or unwillingness/inability to use effective contraception during the study.

17. Inability to provide informed consent due to significant language barrier, cognitive impairment, or dysphasia.

18. Simultaneous participation in another interventional clinical trial or trial participation in any other clinical study 30 days prior to enrollment.

19. Subjects enrolled that are later determined to have non-high-grade gliomas will be considered a screen failure (e.g., Excluded Population), including but not limited to: 19a. IDH-mutant oligodendroglioma, or astrocytoma 19b. Metastasis 19c. Lymphoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FG001 Intraoperative Imaging; 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.	Drug: FG001; FG001 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.; Other Names: Optical imaging agent FG001; Fluorescent imaging agent FG001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperatively, 12 to 19 hours after FG001 administration
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.	Within 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 48 hours postoperatively
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.	Within 48 hours postoperatively
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.	Within 48 hours postoperatively
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.	3 months after surgical resection
Proportion of Subjects With Progression-Free Survival at 6 Months Based on Clinical Evaluation and MRI Assessment Using Response Assessment in Neuro-Oncology Criteria	Progression-free survival at 6 months is defined as the proportion of subjects who remain alive and free from radiographic or clinical progression 6 months after surgical resection. Progression status will be determined by clinical evaluation and MRI assessment using Response Assessment in Neuro-Oncology criteria. Time to progression-free survival event, defined as progression or death, will also be summarized.	6 months after surgical resection
Overall Survival at 6 Months	Overall survival at 6 months is defined as the proportion of subjects who remain alive 6 months after surgical resection.	6 months after surgical resection
Detection Accuracy of Near-Infrared Fluorescence Imaging With FG001 Compared With Histopathological Assessment of Brain Tissue	Detection accuracy of near-infrared fluorescence imaging with FG001 will be assessed by comparison with histopathological assessment of brain tissue specimens obtained from the tumor bulk and tumor margin. Specimen-level calculations will include positive predictive value, negative predictive value, sensitivity, and specificity.	Intraoperatively and following histopathological assessment
Number of Subjects With Adverse Events, Serious Adverse Events, and Clinically Significant Safety Findings Following FG001 Administration	Safety and tolerability of FG001 will be assessed based on adverse events, clinical laboratory parameters, vital signs, and 12-lead electrocardiogram findings. Adverse events will be monitored from screening through Month 6. Clinical laboratory parameters will be assessed at screening, day of surgery, and Day 7. Vital signs will be assessed from screening through Month 6. Electrocardiograms will be assessed at screening, pre-operatively, day of surgery, Day 3, and Day 7.	Adverse events will be monitored from screening, following informed consent, through the Month 6 follow-up visit.

Collaborators and Investigators

• Sponsor: FluoGuide A/S
• Investigators: Study Director: Robert Bilkovski, MD, MBA, Chief Medical Officer, FluoGuide A/S

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: glioma; brain tumor resection
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: FG001-CT-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared with other researchers in order to protect participant privacy and confidentiality. Aggregate study results will be reported as required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No