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Abstract
Introduction. Fluorescence with 5-aminolevulinic acid is usually used for intraoperative assessment of the extent of contrast-enhancing glioma and cerebral metastases resection. Sonography is less frequently used due to its reduced specificity during tumor removal and the inconvenience of shifting focus from the surgical field to the ultrasound monitor. However, the advantage of ultrasound over fluorescence is the ability to detect tumors hidden within normal brain tissue. Currently, there are no published randomized trials comparing the effectiveness of fluorescence and ultrasound in the intraoperative assessment of the extent of brain tumor removal.
Materials and methods. We have planned a randomized single-center, blinded outcome study in 134 patients with two arms and a participant distribution of 1:1. The primary outcome is the extent of glioma or metastasis resection (yes or no). The hypothesis of the trial is that intraoperative sonography is not inferior to fluorescence in intraoperatively assessing the extent of intracranial tumor resections. Block stratified randomization has been performed, with the stratifying variable as the location of the tumor near the motor or speech area of the brain. Patients with single supratentorial contrast-enhancing gliomas or metastases aged 18-79 years with a Karnofsky performance status index of 60-100 % are eligible for randomization. In the study group, sonography will be used for intraoperative assessment of the extent of tumor resection, while in the control group, fluorescence with 5-aminolevulinic acid will be used. Intraoperative magnetic resonance imaging is not planned.
Conclusion. If the primary hypothesis is confirmed, intraoperative sonography may become a worthy alternative to fluorescent-guided surgery based on 5-aminolevulinic acid. The trial is registered with the ClinicalTrials.gov registry as NCT05475522 (SONOFLUO).
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