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

27 maj 2026 uppdaterad av: FluoGuide A/S

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

76

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Donna Haire, Chief Operating Officer
  • Telefonnummer: 4404790511
  • E-post: dh@fluoguide.com

Studera Kontakt Backup

  • Namn: Christopher Bruce, Director, Clinical Operations
  • Telefonnummer: +45 30167903
  • E-post: cb@fluoguide.com

Studieorter

  • Förenta staterna
    • Florida
      • Miami, Florida, Förenta staterna, 33125
    • New Hampshire
      • Lebanon, New Hampshire, Förenta staterna, 03567
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • UPMC Presbyterian Hospital
        • Kontakt:
        • Kontakt:
    • Texas
      • Galveston, Texas, Förenta staterna, 77555
        • University of Texas Medical Branch
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Pablo Valdes, M.D.
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • Optical imaging agent FG001
  • Fluorescent imaging agent FG001

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal Tissue
Tidsram: 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.
Intraoperatively, 12 to 19 hours after FG001 administration
Proportion of Patients Achieving Gross Total Resection Based on Volumetric Analysis of Contrast-Enhanced MRI
Tidsram: 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.
Within 48 hours postoperatively

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of Subjects Achieving RANO Resect Class 1 Based on Early Postoperative MRI
Tidsram: Within 48 hours postoperatively
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
Tidsram: Within 48 hours postoperatively
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
Tidsram: Within 48 hours postoperatively
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
Tidsram: 3 months after surgical resection
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
Tidsram: 6 months after surgical resection
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
Tidsram: 6 months after surgical resection
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
Tidsram: Intraoperatively and following histopathological assessment
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
Tidsram: Adverse events will be monitored from screening, following informed consent, through the Month 6 follow-up visit.
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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

FluoGuide A/S

Utredare

  • Studierektor: Robert Bilkovski, MD, MBA, Chief Medical Officer, FluoGuide A/S

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 juni 2026

Primärt slutförande (Beräknad)

31 juli 2028

Avslutad studie (Beräknad)

31 juli 2028

Studieregistreringsdatum

Först inskickad

12 maj 2026

Först inskickad som uppfyllde QC-kriterierna

21 maj 2026

Första postat (Faktisk)

27 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • FG001-CT-006

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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