Researchers at the Preston Robert Tisch Brain Tumor Center at Duke have enrolled the first patients in a Phase 1 clinical trial evaluating a novel FDA Breakthrough Device designed to safely monitor recurrent glioblastoma in real time. The investigational device, a “tumor monorail,” is a bio-inspired implant placed near the site of tumor recurrence. It creates a controlled pathway that guides invasive tumor cells toward a designated area outside the brain and allows clinicians to obtain repeated samples of live tumor tissue through a minimally invasive outpatient procedure.
The study is the first to combine this real-time monitoring technology with two investigational immunotherapies delivered directly into the tumor using convection- enhanced delivery (CED). By enabling ongoing sampling of tumor tissue during treatment, the device may allow clinicians to better understand how glioblastoma evolves, responds to therapy, or develops resistance without requiring repeat brain surgeries.
The trial is enrolling adults with recurrent glioblastoma who have previously completed standard therapy. Investigators aim to assess the safety and feasibility of the monitoring device while also studying the biologic impact of the investigational drug combination.
To learn more about eligibility and study details, visit clinicaltrials.gov (NCT04547777).