Spinal Tumors

This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.

Stereotactic body radiotherapy (SBRT) is a highly precise, image-guided radiotherapy technique delivering 1-5 high-dose fractions to spinal metastases. Compared with conventional radiotherapy, SBRT enables delivery of a higher biologically effective dose while maintaining high precision. The Institute of Oncology Ljubljana initiated spinal SBRT treatments in 2017 and introduced an institutional SBRT spine protocol in 2019. As SBRT is technically demanding, strict adherence to standardized planning and delivery procedures is essential to ensure treatment quality and patient safety. This clinical program aims to support structured implementation and continuous development of the institutional SBRT spine protocol in routine clinical practice. The study prospectively evaluates treatment-related toxicity and local tumor control following SBRT for spinal metastases in order to monitor treatment safety and effectiveness within the institutional program.

Objective: To identify new central nervous system (CNS) biomarkers to be used for blood-derived liquid biopsy once the blood-brain barrier (BBB), specifically the blood-arachnoid barrier (BAB), has been transiently disrupted by BDF in patients undergoing spine surgery. Design: Single center (Sheba Medical Center), prospective, controlled. Phase: Feasibility study Endpoints: Efficacy The primary endpoint of the study is the elevation in blood concentration of CNS biomarkers following the study procedure compared to biomarkers detected in cerebrospinal fluid (CSF) of the same subject. Safety The primary safety endpoint will be the overall incidence of BDF procedure-related AEs and SAEs, with severity graded according to CTCAE v5.0 criteria. Study population: The study population will include up to 20 patients undergoing spine surgery. Study period: 24 months. Inclusion criteria: 1. Adult subjects over the age of 18 2. Able to sign informed consent 3. Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring. Exclusion criteria: 1. Pacemakers, or other implanted electric medical devices 2. Pregnant or lactating females 3. Major medical, neurologic or psychiatric condition who are judged as unable to fully comply with the study 4. History of skull fractures or previous brain surgery 5. American Society of Anesthesiologists grade \>2 6. Anticoagulants treatment 7. Damage to the dura resulting in CSF leak 8. Patients with seizures/epilepsy Study procedure: 1. Candidates for intradural tumor resection spinal surgery with intraoperative neuromonitoring will be enrolled in the study prior to surgery. 2. The patient will undergo preparation for surgery according to the standard care. 3. Once anesthetized and intubated, electrodes will be attached to the patient's head. 4. After placing the electrodes, when the patient is under anesthesia, a blood sample will be taken prior to BDF. This sample will be used as baseline for BDF. 5. The patient will then undergo a BDF procedure. 6. Additional blood samples will be taken for identification of CNS biomarkers. 7. Surgery will then proceed according to the standard of care. 8. Once the dura is opened, a CSF sample will be taken, in order to compare the blood biomarkers of the specific subject with the CSF biomarkers. 9. The surgery will continue according to the standard of care.

The Swiss Spinal Tumor Registry is a prospective REDCap-based registry, collecting data of surgically treated patients with primary and metastatic tumors of the spine.