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NCT03604978
This phase I/II trial studies the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating patients with grade II-III meningioma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Giving nivolumab and multi-fraction stereotactic radiosurgery with or without ipilimumab may work better in treating patients with grade II-III meningioma.
NCT05278208
This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)
NCT06275919
The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent meningiomas. Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome. Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas. Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice. Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life.
NCT03251989
Background: Primary tumors of the brain and spine are those that start in the brain or spine. These tumors are rare, accounting for \<2% of all cancers diagnosed in the United States. Some of these tumors occur in less than 2,000 people per year. Researchers want to study a large group of people with this kind of tumor. They want to learn more about the tumors, including the risk factors related to how they develop in adults. Objective: To collect health and gene data to learn about what changes are associated with a rare CNS Tumors, to eventually screen for these changes or target the genes in treatment. Eligibility: Adult participants \>= 18 years of age who self- identify as being diagnosed with one of 12 rare CNS tumors, including: Atypical teratoid rhabdoid tumor (ATRT); Brainstem and midline gliomas; Choroid plexus tumors; Ependymoma; High grade meningioma; Gliomatosis cerebri; Medulloblastoma; Oligodendroglioma / Anaplastic oligodendroglioma; Pineal region tumors; Pleomorphic xanthroastrocytoma / Anaplastic pleomorphic xanthroastrocytoma; PNET (Supratentorial embryonal tumor); Primary CNS sarcoma / Secondary CNS sarcoma (Gliosarcoma). Design: Participants will be invited to participate through an ad on the CERN Foundation website (ependymoma), information on the Neuro-Oncology Branch website and other identified advocacy and social media sites and direct mailer to those who have already participated in the EO projects. (Registered Trademark) * Interested participants will complete an enrollment form that will be sent to the study coordinator. * The coordinator will then send the participant a consent form and schedule a time for phone consent. * Participants will complete the Rare CNS tumors Outcomes Survey and once completed, the Rare CNS tumors Risk survey. (Registered Trademark) * The questions on the Outcomes Survey will include treatment history, symptoms social and clinical information and it should take about 25-35 minutes. The Risk survey will cover their demographic information, personal medical history, family medical history and environmental exposures. This should take about 52 minutes. * Participants who have physical problems can have help with the surveys and forms. * Once the surveys are completed, participants will be mailed a kit to collect saliva for germline DNA. Participants will ship the sample to the study team in a prepaid envelope * If the sample is not sufficient, participants will be contacted to give provide an additional sample.
NCT04189172
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
NCT07476404
Project Summary: Retrospective Cohort Study 1. Core ObjectiveThe primary goal is to determine if the volume of Hydroxyethyl Starch (HES) 130/0.4 (specifically Voluven® or Volulyte®) administered during the removal of giant meningiomas (tumors \> 5 cm) increases the risk of postoperative complications. 2. Research Question Does the volume of intraoperative HES solution influence the rate of re-bleeding (requiring a second surgery within 48 hours) or the development of Acute Kidney Injury (AKI) within 7 days after the initial craniotomy?Outcomes: 3. Outcomes Primary: Incidence of re-bleeding at the tumor bed requiring re-operation within 48 hours Secondary: New-onset postoperative AKI within 7 days (defined by KDIGO criteria)
NCT05940493
This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma. Abemaciclib is a drug that is approved by the FDA, but not for brain tumors. Participants who consent to the trial will have surgical tissue collected from the planned surgical resection and tested. If the tissue shows positive results for RB cells and participants are qualified, they will be enrolled and receive study treatment two to five weeks after completing standard-of-care radiation therapy. This is a randomized clinical trial which means that participants will be randomly assigned to a treatment based on chance, like a flip of a coin. Neither the participant nor the researcher chooses the assigned group. Randomization will help the researchers study how the drug works by comparing the difference between the study drug and the placebo and how they work in treating brain tumors. This is a double-blinded study, which means that neither the participant nor the study team will know which treatment the participant is receiving.
NCT02523014
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT04298541
The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.
NCT06377371
The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.
NCT07418775
Meningiomas are the most common primary brain tumor, and some groups are diagnosed with higher-grade tumors and have clinically worse outcomes. This study investigates social determinants of health and individual risk factors that may be associated with meningioma.
NCT07413796
The purpose of this study is to compare two commonly used methods of closing the skin after surgery for an intracranial tumor. Skin closure is one of the most important steps in neurosurgical procedures, as it has a major influence on how well the wound heals. In patients with brain tumors, proper wound healing is especially important because it may affect how soon additional treatments, such as radiotherapy or chemotherapy, can be started. There are different ways to close the skin after surgery, including running sutures and interrupted sutures. Both methods are widely used and considered safe. However, in oncological neurosurgery, there is limited scientific evidence comparing their effects, and the choice of technique is often based on the surgeon's personal experience. In this study, investigators will compare skin closure using running absorbable sutures with interrupted non-absorbable sutures. Investigators will evaluate how well, depending on used suturing methods, the wound heals and how often wound-related complications occur, such as infection, separation of the wound edges, or leakage of cerebrospinal fluid. Investigators believe that the results of this study will help improve wound care in patients undergoing neurosurgical treatment for brain tumors and, as a result, may contribute to better recovery and overall quality of life.
NCT04278118
This phase II trial studies how well hypofractionated proton or photon radiation therapy works in treating patients with brain tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells. A shorter duration of radiation treatment may avoid some of the delayed side effects of radiation while providing a more convenient treatment and reducing costs.
NCT06955208
This prospective single-center study aims to evaluate the feasibility and clinical utility of three-dimensional magnetic resonance elastography (3D MRE) in assessing tumor stiffness and adhesion in patients with meningioma undergoing surgical resection. By correlating preoperative MRE-derived stiffness and adhesion maps with intraoperative findings and histopathological features, the study seeks to determine whether MRE can serve as a noninvasive imaging biomarker for surgical planning, risk stratification, and prediction of tumor behavior.
NCT07282470
Meningiomas are the most common primary intracranial tumors. Current treatment relies on surgical resection and radiotherapy, but molecular predictors for recurrence are lacking. This study aims to investigate epigenetic features, specifically histone post-translational modifications (PTMs) and DNA methylation, to stratify patients. The study involves a retrospective cohort to define an epigenetic signature and a prospective cohort to validate it in tissues and liquid biopsies (plasma/EVs).
NCT07398066
Post-craniotomy pain is common and often undertreated. Inadequate analgesia can lead to patient discomfort and higher opioid consumption, which may result in respiratory depression, sedation risks and impaired neurological assessment in the early postoperative period. The incidence of post-operative delirium after intracranial surgery was 19%, ranging from 12 to 26% caused by variation in clinical features and delirium assessment methods1. It is associated with increased morbidity, longer length of hospital stay, and harm to self or staffs. Dexmedetomidine (Precedex) is a highly selective α2-adrenergic agonist with the properties of analgesia, sedative, anxiolytic and neuroprotection without significant respiratory depression. Most of the trials administered a loading dose of 0.5-1.0 μg/kg intravenous dexmedetomidine over 10 minutes followed by infusion dose 0.2-0.7 μg/kg/hour. The use of intraoperative dexmedetomidine is believed to reduce the usage of postoperative opioids where frequent neurological assessment is often required in neurosurgical patients. Beyond the benefit of analgesia, perioperative dexmedetomidine has been studied for prevention of postoperative delirium. Randomized trials in mixed noncardiac surgical populations reported that low-dose perioperative dexmedetomidine may reduce the incidence of delirium. Dexmedetomidine produces dose-dependent bradycardia and hypotension, which should be carefully monitored to maintain the cerebral perfusion pressure in brain surgery. However, most trials and meta-analyses have focused on general surgical or cardiac cohorts; the evidence remains limited in neurosurgical (craniotomy) patients. Although it showed promising benefits of analgesia and neuroprotection in non-neurosurgical patients, recent meta-analyses of intraoperative dexmedetomidine reported high degree of heterogeneity due to the inclusion of varied procedures (elective vs emergent craniotomy), dosing regimes (loading dose only versus loading dose + infusion versus infusion only) and varied primary endpoints (postoperative pain scores, cumulative opioid consumption or incidence of delirium). Therefore, this randomized, double-blind, placebo-controlled trial is designed to examine the use of intravenous dexmedetomidine in the reduction of postoperative pain score and delirium in neurosurgical patients. We hypothesised that intravenous dexmedetomidine reduces postoperative pain score and delirium with lower need of rescue analgesia and amount of morphine consumption in patients undergoing craniotomy.
NCT05139277
The primary objective of this study is to evaluate the diagnostic performance of the CONVIVO confocal endomicroscope in discriminating between normal and abnormal tissue in vivo during brain tumor surgery. The interpretation of intraoperative images obtained in situ will be tested against conventional histologic evaluation of targeted biopsies from imaged tissue. The study team hypothesize that there will be a high degree of correlation between images obtained with the CONVIVO system and conventional histologic interpretation.
NCT03180268
This randomized phase III trial studies how well radiation therapy works compared with observation in treating patients with newly diagnosed grade II meningioma that has been completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.
NCT04113395
Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series. The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. However, the use of some of these products is problematic, due to gadolinium deposits observed in patients who have had several injections during their lifetime, especially in patients followed for multiple sclerosis. Recently, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued recommendations concerning the screening of meningiomas in patients at risk, particularly in people treated with cyproterone acetate. It is a synthetic progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic syndromes in women or in the palliative treatment of prostate cancer in men. Its long-term use seems to be associated with a significant over-risk of developing meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of 60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM recommends that a cerebral MRI be performed at the beginning of treatment for all patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI at 5 years is normal. These recommendations will lead to a large number of MRIs involving an injection of contrast agent in this population, with potential immediate or delayed serious adverse effects. New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized for contrast detection, have been developed. These could detect meningeal anomalies and more particularly meningiomas without contrast injection, or with a significantly lower dose of contrast agent. These techniques have not been specifically studied for screening or monitoring meningeal lesions, but it seems relevant and important to be able to validate protocols that reduce gadolinium doses given the high number of screening and follow-up MRIs in the general population. Patients presenting for brain MRI screening or meningioma follow-up will have the usual MRI sequences for their management, and the sequences performed at 1/6th of the standard dose of Gadolinium that are added for research. These new sequences will add approximately 6 minutes of additional examination time.
NCT06804655
Advanced technology of ex vivo drug profiling referred to as pharmacoscopy may allow to identify novel drugs for the treatment of glioblastoma and other refractory brain tumors at an individual patient level. This personalized therapeutic approach was developed and validated in pre-clinical glioma models. With the current research proposal, we seek to establish feasibility for a clinical interventional trial for patients with refractory primary brain tumors that is based on pharmacoscopy-guided selection of treatment. The study is supported by an unrestricted grant from Anti Cancer Fund.