FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma (NCT07609472)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Miami — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- University of Miami — Miami, Florida
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire
- UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania
- University of Texas Medical Branch — Galveston, Texas
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (440) 479-0511
Email: dh@fluoguide.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All High-Grade Glioma (WHO III-IV) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.