Dmitriev, A. Y., Dashyan, V. G., Prirodov, A. V., & Khamidova, L. T. (2024). Intraoperative Sonographically Guided Resection of Non-Enhancing Diffuse Gliomas: Study Protocol for a Randomised, Controlled Trial. Voprosy Onkologii, 70(1), 48–55. https://doi.org/10.37469/0507-3758-2024-70-1-48-55

Abstract

Introduction. Intraoperative sonography in surgery of non-enhancing gliomas has a number of advatages, which are real-time evaluation of tumor, multiple scans, absence of contraindications, and low cost of the equipment. Current evidence for the feasibility of sonography in the management of such tumours is low.

Methods. This is a single-center two arm randomized controlled superiority trial on 96 patients with a 1:1 allocation ratio. Primary endpoint is the extent of glioma resection (in percents). The hypothesis of the study states that the use of intraoperative sonography increases the extent of resection of non-enhancing gliomas. Block stratified randomization is provided, the stratification criterion is the location of a glioma next to the motor or speech area of the brain. The trial will include newly diagnosed solitary supratentorial non-enhancing gliomas in patients aged 18-79 years with Karnofsky performance status 60-100 %. Sonography will be used in the study group to intraoperatively assess the extent of tumor removal. In the control group, the tumor will be removed under visual control only. Intraoperative magnetic resonance imaging and fluorescence will not be used.

Conclusion. If the hypothesis is confirmed, the study will allow to more widely introduce intraoperative sonography in the surgery of brain non-enhancing gliomas and to increase the extent of their resection.

Trial registration. The study is registered with the ClinicalTrials.gov registry under the number NCT05470374 (SONOGLIO).

https://doi.org/10.37469/0507-3758-2024-70-1-48-55

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