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

Conditions

• High-Grade Glioma (WHO III-IV)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FG001 — DRUG
  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 Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

76 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• 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.

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 ]

Central Contacts

• Donna Haire, Chief Operating Officer
  4404790511
  [email protected]
• Christopher Bruce, Director, Clinical Operations
  +45 30167903
  [email protected]

Locations (5)

Find similar trials in Miami, FL

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