Fluorescence-guided Surgery for Low- and High-grade Gliomas
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat.
Mounting evidence suggests that survival improves with greater tumor removal, yet being able
do a complete removal can be difficult due to the tumor's infiltrating nature.
5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3
hours before surgery, is selectively taken up by glioma cells and causes a red/pink
fluorescence (glow) under a blue light that allows tumor margins to be seen during the course
of surgery. While this compound is used as a standard-of-care agent in Europe, it remains
under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany,
however, has demonstrated a significant improvement in the rate of complete resection for
certain brain tumors (65% vs. 34%).
The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on
the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special
microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the
tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the
special microscope during surgery will greatly lower the amount of tumor left behind.