View clinical trials related to Brain Tumor.
Filter by:The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are: Does niraparib improve progression-free survival (PFS) compared to TMZ? Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. - study drug (Niraparib) or - comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: - Complete study visits as scheduled - Complete a diary to record study medication
Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology.
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.
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.
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.
The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study. The primary objectives of this study are: - To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. - To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.
Background: Approximately 480 primary, non-pituitary, brain tumours were diagnosed in Ireland each year between 1994 and 2013. Recent developments in treatment have greatly improved survival for younger patients in the 15-54 age range. The Irish National Neurosurgical Centre and the St Luke's Radiation Oncology Centre at Beaumont Hospital and treat approximately 200 patients with brain tumours per year with a combination of surgery, radiotherapy (RT) and chemotherapy with RT being the most commonly used treatment modality. With improved survivorship, the prospect of individuals living for several decades with co-morbidities induced by the tumour itself or surgical and RT treatments, raises new and complex issues for patients and clinicians. The hypothalamus and pituitary gland in the brain are the key regulators of hormone action. They control several hormone systems including reproductive function (FSH, LH) growth (growth hormone), thyroid (TSH) and adrenal function (ACTH) as well as many other homeostatic mechanisms. It has long been recognised that therapeutic cranial RT to the pituitary gland causes hypothalamic-pituitary dysfunction (hypopituitarism). Traditionally, high-risk groups for post-irradiation hypopituitarism were considered to be patients with pituitary tumours, survivors of childhood cancer and patients who received high-dose RT to treat nasopharyngeal cancers. The potential for cranial radiotherapy to cause significant pituitary dysfunction in adult patients with brain tumours has received little attention. The assumption has been that the hypothalamic-pituitary axis is more resistant in adults than in children to the effect of cranial RT. However, it is likely that the higher doses of RT, used to treat primary brain tumours in adults, causes significant hypothalamic-pituitary dysfunction resulting in hypopituitarism. Preliminary data from the National Pituitary Centre in Beaumont Hospital has revealed that adult patients, treated with cranial radiotherapy for primary, non-pituitary brain tumours, are at risk of hypopituitarism. Approximately 40% of patients had pituitary deficiencies in at least one hormone axis, while 25% of patients had deficiencies in multiple hormone axes. Hypopituitarism confers significant morbidity and increased mortality to patients. At present, adult survivors of brain tumours are referred to the pituitary service for assessment on an ad-hoc basis meaning that many patients with hypopituitarism may go undiagnosed. In addition to the challenges caused by hypopituitarism, long-term neuropsychological outcomes following a brain tumour cause significant functional impairments and reduced HR-QOL. Patients can present with impairments in specific cognitive domains such as memory and executive functioning or more global systems such as attention as well as significant issues with fatigue. In addition to these primary deficits, patients can also present with significant distress, fluctuant mood and anxiety. Despite the impact of brain tumours can exert, the National Cancer Control Program's National Survivorship Needs Assessment Review (2019) did not identify any studies reporting the needs of adult survivors of brain tumours in Ireland. There is an urgent need to understand the impact of hypopituitarism and its treatment on HR-QOL and neuropsychological functioning. The proposed study will add to the limited existing literature on the prevalence of hypopituitarism in adult survivors of brain tumours treated with radiotherapy and generate detailed information on deficiency rates for individual pituitary hormones and how these deficiencies emerge over time. This will also be the first study to examine if treatment of radiotherapy-induced hypopituitarism (as part of routine clinical care) is associated with improved HR-QOL and neuropsychological functioning.
This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.
The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy
In the experimental group, norepinephrine at a concentration of 5 mcg/ml is preemptively administered through peripheral venous catheter with a size of 20 G or more from the time of anesthesia induction to the end of anesthetic administration. The norepinephrine is not preemptively administered in the control group. For anesthesia, total intravenous anesthesia using propofol and remifentanil is performed. During anesthesia, the injection rate of the test drug is allowed to be adjusted according to the blood pressure within the permissible range, and anesthesia management such as fluid infusion, blood transfusions, and drug administration is performed according to the judgment of the anesthesiologist, and there are no restrictions. The achievement of hemodynamic stability during anesthesia is judged by the percentage (%) of the time when the target blood pressure falls outside of 90-110%, 80-120%, and 70-130% of the target blood pressure during the total anesthesia duration. The number of hemodynamic unstability occurred, and the number of patients with hemodynamic unstability are also sought. The incidence of postoperative complications between the two groups is also compared.