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

2026년 5월 27일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

76

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Donna Haire, Chief Operating Officer
  • 전화번호: 4404790511
  • 이메일: dh@fluoguide.com

연구 연락처 백업

  • 이름: Christopher Bruce, Director, Clinical Operations
  • 전화번호: +45 30167903
  • 이메일: cb@fluoguide.com

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
다른 이름들:
  • Optical imaging agent FG001
  • Fluorescent imaging agent FG001

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Tumor-to-Background Ratio of Near-Infrared Fluorescence Imaging of Tumor Bulk In Situ and Adjacent Normal Tissue
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of Subjects Achieving RANO Resect Class 1 Based on Early Postoperative MRI
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

FluoGuide A/S

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 30일

기본 완료 (추정된)

2028년 7월 31일

연구 완료 (추정된)

2028년 7월 31일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 21일

처음 게시됨 (실제)

2026년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 27일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FG001-CT-006

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

고급 신경 교종 (WHO III-IV)에 대한 임상 시험

FG001에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Djibouti

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다