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Brain Tumor clinical trials

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NCT ID: NCT06368310 Not yet recruiting - Glioma Clinical Trials

FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are: - To understand the safety of these new electrodes when used during brain tumor surgery (primary objective); - To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives). Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery.

NCT ID: NCT06352710 Recruiting - Brain Tumor Clinical Trials

Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project

Start date: June 12, 2023
Phase:
Study type: Observational

Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality. The increasing use of smartphones offers unprecedented opportunities for data collection. We developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity). By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, we aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. We will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. We hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making.

NCT ID: NCT06330298 Recruiting - Stroke Clinical Trials

Improving Social Cognition and Social Behaviour in Various Brain Disorders

T-ScEmo4ALL
Start date: May 31, 2021
Phase: N/A
Study type: Interventional

Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients. Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019). Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders. It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.

NCT ID: NCT06329570 Not yet recruiting - Neoplasms Clinical Trials

Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

NCT ID: NCT06314607 Not yet recruiting - Brain Tumor Clinical Trials

Genetic and Molecular Characterization of Nervous System Lesions

ONCONEUROTEK 2
Start date: May 2024
Phase:
Study type: Observational

Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets. Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies). In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile. This project aims to make a decisive contribution to these objectives.

NCT ID: NCT06257498 Completed - Brain Tumor Clinical Trials

Upright Open MRI for Brain Imaging in Children - a Pilot Study

Heads-Up
Start date: January 25, 2022
Phase: N/A
Study type: Interventional

PRIMARY OBJECTIVE To establish feasibility and acceptability of diagnostic brain MRI in young children for specified indications using an upright MRI system without sedation or anaesthesia. SECONDARY OBJECTIVES To establish how young children who undergo brain MRI using upright MRI view the experience To establish how parents / carers of young children who undergo brain MRI using the upright MRI view the experience for their child and for themselves. To establish how image quality compares between brain MRI using the upright MRI scanner and the standard MRI scanner used in clinical practice.

NCT ID: NCT06251830 Completed - Multiple Sclerosis Clinical Trials

Increasing Diagnosis Rates While Reducing Examination Time: Can MR Fingerprinting Deliver on Its Promise?

Start date: September 1, 2018
Phase:
Study type: Observational

Magnetic Resonance Imaging (MRI) is an excellent method for diagnosis and staging of brain disease. However, lengthy scan times and sensitivity to patient motion limit its efficacy. To address this, a novel method has recently been demonstrated, called MR Fingerprinting (MRF). The investigators' improved implementation of MRF, featuring fully-quantitative data and a reduced sensitivity to patient motion, can be used to acquire an anatomical exam in less than five minutes at a standard resolution. The potential for wide applicability of this technique, combined with an implied reduction in complexity and cost of MRI exams, has generated wide interest. However, published studies have been limited to demonstrations in healthy volunteers, and the effectiveness of MRF in the clinical practice has not yet been proven. Here, the investigators aim to assess the efficacy of MRF in performing diagnostic exams avoiding sedation in children and for increasing diagnosis rates in challenging adult patients.

NCT ID: NCT06229483 Recruiting - Brain Tumor Clinical Trials

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

Start date: April 3, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to test the effect of a drug called tranexamic acid (TXA) on reducing blood loss in participants undergoing surgery to remove brain tumors. The main questions it aims to answer are: 1. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA reduce the amount of estimated blood loss during surgery? 2. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg/kg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg/kg/hr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.

NCT ID: NCT06199050 Recruiting - Breast Cancer Clinical Trials

The Effect of 360° Virtual Reality Movies on Fear and Anxiety

ENGAGE
Start date: June 16, 2023
Phase: N/A
Study type: Interventional

To assess the effect of web-based 360° Virtual Reality movies on fear and anxiety, The investigators would like to assess the patient-perceived level of fear and anxiety quantitatively, making use of several questionnaires.

NCT ID: NCT06193759 Not yet recruiting - Brain Tumor Clinical Trials

Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)

IMPACT
Start date: February 5, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 4 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.