Safety of an imaging agent in glioma

Background

We supported a Phase 1 clinical trial evaluating the safety, pharmacokinetics and fluorescence imaging capabilities of BLZ-100 in adults with suspected glioma. This novel imaging agent aims to enhance the precision of fluorescence-guided surgery (FGS), offering surgeons a clearer view of cancerous tissue.

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Objective

To assess the safety and efficacy of BLZ-100, particularly its ability to generate fluorescence signals in both high and low-grade gliomas, while ensuring tolerability across dose levels.

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Approach

Leveraging extensive expertise in early-phase trial design and innovative technologies, we:

• developed a trial strategy that met regulatory and clinical objectives
• provide insights into dose-escalation methodologies to ensure safe and effective evaluation
• facilitated the practical implementation of a novel imaging agent in a real-world clinical setting.

Results

• No dose-limiting toxicity or adverse events related to BLZ-100 were observed.
• Fluorescence signals were successfully detected in both high- and low-grade glial tumors.
• Results demonstrated the safety of BLZ-100 at doses up to 30 mg and suggested its potential utility in FGS for gliomas.

Key takeaways

• Our expertise in trial design and regulatory navigation ensured the study met its safety and efficacy goals.
• The trial demonstrated the potential of BLZ-100 to improve surgical precision for gliomas, supporting further clinical development.
• Practical strategies for introducing advanced diagnostics into clinical settings were effectively implemented.