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FG001 Near-Infrared Fluorescence Imaging for High-Grade Glioma Surgery

This study is testing FG001, an investigational optical imaging agent, to see if it can help surgeons better identify brain tumor tissue during surgery for newly diagnosed high-grade glioma (a type of aggressive brain cancer). FG001 is a special dye given through an IV before surgery that glows under near-infrared light, potentially making it easier for doctors to tell the difference between the tumor and healthy brain tissue. The main goals are to see how well FG001 highlights the tumor compared to normal tissue during surgery, and if using it helps surgeons remove as much of the tumor as possible. You might be able to join if you are 18 or older and have a brain lesion that looks like high-grade glioma on an MRI.

Study design
This is a single-group study with 76 planned participants, where everyone receives FG001. It is an open-label study, meaning both you and your doctors will know you are receiving FG001.
What's involved
You would undergo screening, receive FG001 12-19 hours before surgery, and then have your planned brain tumor surgery. There will be assessments before, during, and within 48 hours after surgery.
Compensation
Not stated in the trial record.
Follow-up
The main outcomes are measured during surgery and within 48 hours after surgery.

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NCT07609472

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalDiagnostic
FluoGuide A/S
~76 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:FG001

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal Tissue
Measured over Intraoperatively, 12 to 19 hours after FG001 administration
+1 more outcome measured

Conditions

High-Grade Glioma (WHO III-IV)

Explore related trials

AstrocytomaEpendymomaGlioblastomaMalignant GliomaOligodendroglioma1pIDH1 wt Allele

Where it's being run

5 sites across 5 states
Florida1
New Hampshire1
Pennsylvania1
Texas1
Utah1

Study leadership

  • Robert Bilkovski, MD, MBA, Chief Medical Officer · STUDY_DIRECTOR · FluoGuide A/S

Who to contact

Donna Haire, Chief Operating Officer
[email protected]
4404790511
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal TissueIntraoperatively, 12 to 19 hours after FG001 administration

    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 MRIWithin 48 hours postoperatively

    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.