Sammendrag
Background Anovel acoustic coupling fluid (ACF), with the potential to reduce surgically induced image artefacts during intraoperative
ultrasound imaging in brain tumour surgery, has been evaluated with respect to image quality and safety in a clinical phase 1 study.
Methods Fifteen patients with glioblastoma (WHO grade IV) were included. All adverse events were registered in a 6-month
study period. During acquisition of 3D ultrasound image volumes, three different concentrations of the ACF and Ringer’s
solution were filled into the resection cavity. The effect of ACF on the ultrasound images was rated by the operating surgeon,
and by five independent neurosurgeons evaluating a pair of blinded images from all patients. Images from all patients were
analysed by comparing pixel brightness in a noise-affected region and a reference region.
Results The operating surgeon deemed the ACF images to have less noise than images obtained with Ringers’s solution. The
blinded evaluations by the independent neurosurgeons were significantly in favour of ACF (p
Vis fullstendig beskrivelse