Protocol of the observational study STRATUM-OS: First step in the development and validation of the STRATUM tool based on multimodal data processing to assist surgery in patients affected by intra-axial brain tumours

Integrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool. This international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool, and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomized clinical trial. The protocol was approved by the participant Ethics Committees. Results will be disseminated in scientific conferences and peer-reviewed journals. [Pending Number] STRATUM-OS will be the first multicentre prospective observational study to develop and technically validate a 3D decision support tool for brain surgery guidance and diagnostics in real-time based on artificial intelligence and multimodal data processing, including the emerging hyperspectral imaging modality. This study encompasses a prospective collection of multimodal pre, intra and postoperative medical data, including innovative imaging modalities, from patients with intra-axial brain tumours. This large observational study will act as historical control in a subsequent clinical trial to evaluate a fully-working prototype. Although the estimated sample size is deemed adequate for the purpose of the study, the complexity of the clinical context and the type of surgery could potentially lead to under-recruitment and under-representation of less prevalent tumour types.