This observational study (STRATUM-OS) aims to collect the necessary data from a cohort of patients with planned surgery for suspected intra-axial malignant brain tumours (both primary and secondary) following the standard surgical procedure established in current clinical protocols. These data will serve two primary purposes:
i) To gather multimodal data (pre, intra and postoperative) essential for the development and technical validation of a 3D decision support tool for brain surgery guidance and diagnostics integrating augmented reality and multimodal data processing powered by artificial intelligence algorithms (called STRATUM tool);
ii) To collect outcome measures that will facilitate a subsequent comparative study (a non-randomized controlled clinical trial, called STRATUM-NRCCT) assessing the standard procedure alone versus the standard procedure augmented with the STRATUM tool. Patients from STRATUM-OS will act as a historical control group in the subsequent historically controlled clinical trial (STRATUM-NRCCT), which will be performed once STRATUM-OS has been completed.
In STRATUM-OS patients will receive standard care as per established clinical protocols, with no modification to their treatment. However, patients will be asked to grant access to their clinical information, complete questionnaires, and provide relevant pre, intra and postoperative information related to the surgical intervention. Data will be gathered from multiple sources, such as the Electronic Health Records (EHR), patient completed questionnaires, interviews, and reports from healthcare professionals involved in the surgical procedure. Additionally, intraoperative data will be collected from the different devices in the operating room.
Adult patients (≥18 y/o).
Patients with planned surgery for suspected intraaxial malignant brain tumours (both primary and secondary) at any of the participating clinical institutions.
Inability to deliver informed consent (unless provided by the tutor).
Participants in this study who have already undergone brain surgery during STRATUM-OS and need a revision surgery.
Participantion in this study will be proposed to adult patients with planned surgery for suspected intraaxial malignant brain tumours (both primary and secondary). Patients will be recruited at the 3 participant clinical sites: * Hospital Universitario de Gran Canaria Doctor Negrin (HUGCDN), Las Palmas de Gran Canaria, Spain; * Karolinska University Hospital (KUH), Solna, Sweden; * Hospital Universitario 12 de Octubre (HU12O), Madrid, Spain; Recruitment will be performed via consecutive inclusion of subjects fulfilling the inclusion criteria and none of the exclusion criteria at the participating clinical institutions.
Case-only
Prospective
Not listed
STRATUM Tool intraoperative tumour identification against anatomopathological analysis
The primary outcome measure consists of the histopathological classification of resected tissue samples as "tumour" or "non-tumour", which will serve as the reference standard for technical validation. The STRATUM tool's performance in intraoperative tumour tissue identification will be evaluated against this reference using a three-way data partitioning approach (training, validation, and test sets), with evaluation metrics including sensitivity, specificity, positive and negative predictive values, and/or receiver operating characteristic (ROC) curve analysis. These performance metrics will be calculated at the tissue sample level using the test set.
STRATUM Tool intraoperative identification of Contrast Enhancing Tumour (CET) or non-Contrast Enhancing Tumour (nCET) (FLAIR positive)
The secondary outcome measure consists of the radiological classification of tumour regions as CET or nCET (FLAIR-positive) based on preoperative and postoperative MRI scans, which will serve as the reference standard for the evaluation of STRATUM's intraoperative imaging-based segmentation. Using a three-way data partitioning approach at the patient level (training, validation and test sets), the agreement between STRATUM-based segmentation and radiological diagnosis will be assessed in the test set using sensitivity, specificity, positive/negative predictive values, Jaccard Index and/or the Dice-Sørensen coefficient.
Data collection for technical validation and the generation of a historical control group
All data collected from patients enrolled in STRATUM-OS will serve as a historical control group for the subsequent study (the non-randomized controlled clinical trial, STRATUM-NRCCT). This trial will compare standard neurosurgical procedures with and without the use of the STRATUM tool for decision-support during surgery. The STRATUM-NRCCT will be conducted upon the completion of STRATUM-OS. The collected measures will span from patient enrolment to the end of the 6-month follow-up after surgery and will be categorized in the following main domains: * Patient characteristics * Patient´s symptoms * PROMs (Patient-Reported Outcome Measures) * Vasari guide variables * Surgery details * Intraoperative pathology * Definitive pathology * Definitive pathology (STRATUM-related samples) * Exitus * Postoperative MRI outcomes * Complications * Medication * Emergency and hospital readmissions * Follow-up MRI * Treatments * Hospital stay * Follow-up visits to professionals * Follow-up tests
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Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Lead sponsor
Karolinska University Hospital
Collaborator
Hospital Universitario de Gran Canaria Doctor Negrín
Collaborator
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
Collaborator
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