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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
5
ultrasound images obtained with both ACF and Ringer's acetate
ultrasound images obtained with Ringer's acetate only
Department of Neurosurgery, St Olavs Hospital
Trondheim, Norway
difference in serious adverse event rates (test minus control)
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
Time frame: 72 hours
difference in serious adverse event rates (test minus control)
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
Time frame: 30 days
difference in serious adverse event rates (test minus control)
Non-inferiority (i.e. test serious adverse event rate is "not worse" than control) is shown if the 95%-confidence interval around the mean difference in event rates has an upper value below 0.3 which is the predefined margin
Time frame: 6 months
image artefacts
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
Time frame: 1 day
image artefacts
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
Time frame: 1 day
depiction of outline of the anatomy surrounding the resection cavity
during the operation; Qualitative score of ultrasound image quality (poor-medium-good)
Time frame: 1 day
depiction of outline of the anatomy surrounding the resection cavity
during the operation; Qualitative score of artefacts in ultrasound images (none-some-much)
Time frame: 1 day
image signal-to-noise ratio
after the operation: image analysis by quantitative measurements of signal-to-noise ratio (SNR)
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.