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NCT07224451
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.
NCT02013297
The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
NCT01637766
Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a clinical entity known as cord compression that manifests with progressive loss of motor function and sensation in the legs, as well as bladder and bowel incontinence. The treatment of spinal metastases is mostly palliative with the goals of improving or maintaining neurologic function, achieving local tumor control, and spinal stability. Most patients with spinal metastatic disease are currently treated effectively with radiation therapy and/or surgery with good results. There are however certain limitations in the current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted SMD is in close proximity the spinal cord, delivery of high radiation doses is contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and 2) there is limit on the cumulative amount of radiation dose, which means that recurrent tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned, the main limitation is that some patients are not fit for surgery because of medical co-morbidities. This phase I clinical research trial will test the hypothesis that a new minimally invasive treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients with SMD.
NCT00631670
The purpose of this research study is to determine if Stereotactic Body Radiation Therapy (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5 continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15 Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.