High-Grade Glioma (WHO III-IV)Phase 2NCT07609472
FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma
A Phase 2 study testing FG001 in people with High-Grade Glioma (WHO III-IV), run by FluoGuide A/S at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-Grade Glioma (WHO III-IV)
- What is being tested?
- FG001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2026to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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)
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- Ependymoma (CNS WHO Grade 3)
- No prior tumor-specific treatment, including surgery, chemotherapy, radiotherapy, or investigational therapy (i.e., newly diagnosed, treatment-naïve HGG).
- Subject is scheduled to undergo first neurosurgical intervention with the intent of GTR of the contrast-enhancing lesion.
- Surgery must be clinically anticipated to allow GTR, defined as removal of ≥98% of contrast-enhancing tumor, based on neurosurgeon assessment and preoperative imaging.
- 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.
- KPS ≥70, as assessed within 14 days prior to study treatment. Subject must not previously have received the trial drug (FG001).
- 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.
- 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).
- Subject is capable of understanding and giving written informed consent
Who cannot join
- 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.
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Texas Medical Branch
Galveston, Texas, 77555
Pablo A Valdes, M.D., 603 410 7225, paavalde@utmb.edu
Chisom Onwunyi, 409 266 0247, chonwuny@UTMB.EDU
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03567
Linton Evans, M.D., (603) 650-5109, Linton.T.Evans@Hitchcock.org
Nathan Simmons, M.D., (603) 650-5109, Nathan.E.Simmons@Hitchcock.org
University of Miami
Miami, Florida, 33125
Michael Ivan, M.D., 973-563-4755, mivan@med.miami.edu
Roxane Mayrand, 786-348-7211, r.mayrand@umiami.edu
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Constantinos G. Hadjipanayis, M.D., 412-647-6781, hadjipanayiscg2@upmc.edu
Kristy Boggs, 412-647-8952, boggskd@upmc.edu
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Randy Jensen, M.D., 801 585 0617, randy.jensen@hsc.utah.edu
Rachel Kingsford, 801 585 0115, rachel.kingsford@hci.utah.edu
About this study
Official title: 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.
Read more
The main questions it aims to answer are:
- 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.
- 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.
Read the 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.
- Conditions
- High-Grade Glioma (WHO III-IV)
- Being tested
- FG001
- Keywords
- glioma, brain tumor resection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG001Drug
Also called Optical imaging agent FG001, Fluorescent imaging agent 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.
| Study group | Role | What they receive |
|---|---|---|
| FG001 Intraoperative Imaging | Experimental | 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. Receives: Drug: FG001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 48 hours postoperatively
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Adverse events will be monitored from screening, following informed consent, through the Month 6 follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Glioma (WHO III-IV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm study in which all enrolled participants will receive a single dose of FG001 prior to neurosurgical tumor resection under near-infrared fluorescence guidance. There is no randomization or concurrent control group.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FluoGuide A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bilkovski, MD, MBA, Chief Medical Officer, Study director, FluoGuide A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609472
- Sponsor's protocol ID
- FG001-CT-006
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07609472
- Acronym / sponsor ID
- FG001-CT-006
- Conditions
- High-Grade Glioma (WHO III-IV)
- Keywords
- glioma, brain tumor resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- FluoGuide A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm study in which all enrolled participants will receive a single dose of FG001 prior to neurosurgical tumor resection under near-infrared fluorescence guidance. There is no randomization or concurrent control group.
| Arm | Type | Receives |
|---|---|---|
| FG001 Intraoperative Imaging | Experimental | Drug: FG001FG001 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- 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:
- No prior tumor-specific treatment, including surgery, chemotherapy, radiotherapy, or investigational therapy (i.e., newly diagnosed, treatment-naïve HGG).
- Subject is scheduled to undergo first neurosurgical intervention with the intent of GTR of the contrast-enhancing lesion.
Key exclusion criteria (21 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG001Also: Optical imaging agent FG001, Fluorescent imaging agent FG001FG001 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. | Drug | FG001 Intraoperative Imaging |
Primary outcome
Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal Tissue
Time frame: Intraoperatively, 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 MRI
Time frame: Within 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.
8 secondary outcomes
Proportion of Subjects Achieving RANO Resect Class 1 Based on Early Postoperative MRI
Time frame: Within 48 hours postoperatively
Proportion of Subjects Achieving Response Assessment in Neuro-Oncology Resect Class 2 Based on Early Postoperative MRI
Time frame: Within 48 hours postoperatively
Proportion of Subjects Classified as Response Assessment in Neuro-Oncology Resect Class 3 Based on Early Postoperative MRI
Time frame: 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
Time frame: 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
Time frame: 6 months after surgical resection
Overall Survival at 6 Months
Time frame: 6 months after surgical resection
Detection Accuracy of Near-Infrared Fluorescence Imaging With FG001 Compared With Histopathological Assessment of Brain Tissue
Time frame: Intraoperatively and following histopathological assessment
Number of Subjects With Adverse Events, Serious Adverse Events, and Clinically Significant Safety Findings Following FG001 Administration
Time frame: Adverse events will be monitored from screening, following informed consent, through the Month 6 follow-up visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bilkovski, MD, MBA, Chief Medical Officer study director
FluoGuide A/S
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FG001 in people with High-Grade Glioma (WHO III-IV), run by FluoGuide A/S at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna Haire, Chief Operating Officer (4404790511, dh@fluoguide.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal Tissue (time frame: Intraoperatively, 12 to 19 hours after FG001 administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.