Glioma Clinical Trial
Official title:
Improving Ultrasound Images in Brain Tumour Surgery With the Use of an Acoustic Coupling Fluid Mimicking Brain Tissue: a Phase II Technical and Safety Study
Tools for improving brain tumor surgery, in particular for gliomas, are increasing. There
seems to be an agreement that achieving extensive resections, when done safely without
jeopardizing neurological function, improves survival.
Ultrasound is currently used as a tool for providing 2D or 3D images for tumor localization
and resection control. For the use in resection control the resection cavity is filled with
saline to provide acoustic coupling between the ultrasound transducer and tissue. However,
attenuation of acoustic waves is very low in saline compared to the brain and this difference
in attenuation is the cause of artifacts that may severely degrade the ultrasound images.
Such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. The
artificial signal enhancement can potentially mask small tumor remnants and is generally
making the interpretation of images more difficult.
This research group has developed an acoustic coupling fluid intended for use in the
resection cavity instead of saline. Tests in laboratory measurements have shown that the
fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain
tumor surgery. Three different concentrations of the acoustic coupling fluid have been tested
in a phase 1 study that included 15 patients with glioblastoma. The concentration that
provided the optimal ultrasound images, from qualitative and quantitative inspection, is used
in the current phase II study. This study is a randomized controlled trial aiming to include
82 patients with glial brain tumours. Its purpose is to test the fluid during surgery of
glial brain tumours to further investigate safety and efficacy.
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