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Spinal Cord Neoplasms clinical trials

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NCT ID: NCT06120426 Recruiting - Surgery Clinical Trials

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

NCT ID: NCT06042946 Recruiting - Clinical trials for Radiotherapy; Complications

Microsurgical Resection of Intramedullary Spinal Cord Metastases

Start date: September 1, 2023
Phase:
Study type: Observational

The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients. The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively. Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients. The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment. Primary endpoint (analysed in surgically treated ISCM patients): Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability. Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment): - Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy. - Ambulatory status and continence at 90 days, 6 & 12 months (determined by mJOA subscores) - Neurological outcome, measured by American Spinal Cord Injury Association (ASIA) - Impairment Scale at 90 days, 6 and 12 months - Rate & type of complications at 90 days after treatment according to The Novel Therapy - Disability-Neurology Grade (TDN grade)16 - Overall survival (in days)

NCT ID: NCT05957679 Recruiting - Spinal Cord Tumors Clinical Trials

MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

In spinal cord tumors requiring surgical intervention, the resection difficulty is determined by two significant factors: tumor stiffness and adhesion to surrounding tissue. The stiffness of the tumor dictates the complexity of removal, while strong adhesion presents additional challenges during the surgical procedure. This clinical trial aims to assess the clinical utility of magnetic resonance elastography (MRE), in evaluating the stiffness and adhesion of spinal cord tumors and guiding surgical planning to selecting the most appropriate surgical approach for patients with spinal cord tumors.

NCT ID: NCT05856370 Recruiting - Spinal Deformity Clinical Trials

The Ailliance Post-Market Clinical Study

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively for up to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

NCT ID: NCT05678608 Recruiting - Spinal Cord Tumor Clinical Trials

Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors

Start date: December 13, 2022
Phase: N/A
Study type: Interventional

Primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (IDEM: 65%), and intramedullary The most commonly seen IDEM tumors are schwannomas, neurofibromas, and meningiomas. [1] The less frequently encountered IDEM tumors include ependymomas, lipomas, hemangiomas, metastatic deposits, paragangliomas, nerve sheath myxomas, and vascular tumors.[2] Spinal cord tumors can cause different signs and symptoms, especially as tumors grow. The tumors may affect spinal cord or the nerve roots, blood vessels or bones of spine. Signs and symptoms may include: Pain at the site of the tumor due to tumor growth Back pain, often radiating to other parts of body Feeling less sensitive to pain, heat and cold Loss of bowel or bladder function Difficulty walking, muscle weakness . MRI is the investigation of choice,however other investigation such CT or X ray are important to ensure stability of the vertebral column and the optimal management is gross total excision for symptomatic lesions.[3,4] Over the years, there has been no significant change in the clinical symptoms and pathology of IDEM tumors. However, there have been dramatic improvements in the diagnosis and treatment with the advances of radiological and surgical techniques. Despite advances in operative techniques and neuroimaging, the morbidity associated with the resection of IDEM tumors continues to be significant [5,6]. Here, we examined the surgical outcomes of 20 patients with IDEM spinal cord tumors operated in Neurosurgery department at Sohag university Hospital

NCT ID: NCT05664438 Recruiting - Clinical trials for Spinal Cord Tumor of Cervical Spine

3T MRI of Intramedullary Spinal Cord Tumours

Start date: October 17, 2022
Phase:
Study type: Observational

Intramedullary spinal cord tumours (IMSCTs) are a type of tumour that arises from cells within the spinal cord. They are rare, accounting for around 4-10% of central nervous system tumours. They commonly present as back/neck pain and have poor outcomes if not treated. IMSCTs fall into various subtypes. Around 90% are either ependymomas or astrocytomas. Ependymomas are usually quite distinct from the surrounding tissue and therefore can often be treated successfully with surgery. In contrast, astrocytomas tend to invade the surrounding tissue and, as a result, generally cannot be entirely surgically removed. Radiotherapy is recommended instead of surgery for tumours that cannot be operated. Unfortunately, ependymomas and astrocytomas can appear very similar on diagnostic scans and are therefore difficult to tell apart before surgery. Biopsy therefore remains the current gold standard for tumour subtype differentiation. Any spinal cord surgery, whether it be biopsy or resection, poses major challenges due to the small size of the spinal cord. A small corridor via the back of the spinal cord, known as the posterior midline, usually offers the safest approach to a tumour. However, finding this access corridor can be very difficult because tumours tend to deform the anatomy of the spinal cord, leading to a high risk of injury to the normal spinal cord tissue or nerves. The primary objective of this pilot study is to test if cutting-edge spinal cord magnetic resonance imaging (MRI) techniques could help to better differentiate between tumour subtypes. The investigators will do this by comparing various imaging metrics between the tumour subtypes, confirmed by biopsy. The investigators' second objective is to see if these MRI techniques could help to identify, pre-surgery, the location of the posterior midline of the spinal cord. The investigators will do this by comparing the prediction of the midline location from imaging with blinded observations by the surgeon during planned surgery. Additionally, the investigators want to investigate the relationship between imaging metrics and patient pain and sensorimotor symptoms, to explore if imaging offers insight into the variety of clinical symptoms associated with these tumours. The investigators' hope is that the results of this study could inform a future larger trial that would be designed to fully assess the utility of cutting-edge MRI techniques for reducing both the need for spinal cord surgery and the risks associated with surgery in IMSCT patients.

NCT ID: NCT05631002 Recruiting - Spinal Tumor Clinical Trials

Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors

Start date: August 1, 2022
Phase:
Study type: Observational

Fat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.

NCT ID: NCT05296889 Recruiting - Clinical trials for Degenerative Disc Disease

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

CERISE
Start date: July 21, 2021
Phase:
Study type: Observational

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

NCT ID: NCT05204290 Recruiting - Cancer Clinical Trials

Study of Combined Decompressive Spine Radiosurgery and Pembrolizumab

Start date: March 28, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of this research study is to find out what effects (good and bad) Pembrolizumab and radiosurgery have on participants with high-grade epidural disease of the spine.

NCT ID: NCT05170815 Recruiting - Spinal Deformity Clinical Trials

Clariance ErYs Registry

ErYs
Start date: January 17, 2022
Phase:
Study type: Observational

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.