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Meningioma clinical trials

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NCT ID: NCT06466720 Not yet recruiting - Quality of Life Clinical Trials

Measuring and Mapping Cognitive Decline After Brain Radiosurgery

CoDeB-Rad
Start date: June 10, 2024
Phase:
Study type: Observational

Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. We do not currently know if, or how much, SRS affects brain function. Patients with brain tumours do not get tested routinely for their brain function. Understanding short- and long-term side-effects is important for SRS. Brain metastases patients have short life expectancies (6-months to 1-year). However, meningioma patients can live 10 years or more. SRS is used to treat both. We will use the Montreal Cognitive Assessment (MoCA) to test your brain function. We will use quality-of-life questionnaires QLQ-C30 and BN20. These are specific for patients with brain cancer. They include questions about physical and mental wellbeing. Why is it important This study aims to identify areas in the brain that relate to changes in brain function after SRS. These areas can then have the radiation dose reduced to them in future patients, hoping to minimise side-effects. Research Question Which regions of the brain contribute to a decline in brain function following SRS. Study Design This is a single centre observational study with prospective and retrospective collection of data. This study will look at two groups of patients: Group1: Patients will complete the MoCA and two quality-of-life questionnaires before your treatment and every 3 months for a year. Group2: Patients will complete the MoCA and two quality-of-life questionnaires once. We will use these tests, your MRI scans and your SRS treatment plan to identify areas of the brain that are responsible for any problems with your brain function. The participants for Group 1 will be recruited from the SRS Clinics, at City Campus, Nottingham University Hospitals NHS Trust. The participants for Group 2 will be identified through the Mosaiq Oncology Information System. This pilot study is funded by the Midlands Mental Health and Neurosciences Network.

NCT ID: NCT06460467 Not yet recruiting - Meningioma Clinical Trials

Semi-automatic Segmentation Method for Determining 177Lu-DOTATATE Tumor Dosimetry

SSTR
Start date: July 1, 2024
Phase:
Study type: Observational

The aim of this study was to compare a semi-automatic segmentation method with manual reference segmentation to determine an overall tumor volume on post-therapy scintigraphy at D1 in patients treated with 177Lu-DOTATATE for meningioma or neuroendocrine tumor for dosimetric calculation.

NCT ID: NCT06439420 Not yet recruiting - Glioblastoma Clinical Trials

CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial

CBT-I in PBT
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

This study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.

NCT ID: NCT06377371 Not yet recruiting - Meningioma Clinical Trials

Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

Start date: May 2024
Phase: Phase 4
Study type: Interventional

The study team hypothesizes that it is feasible to intraoperatively detect tumor following [CU64]DOTATATE injection using the gamma probe device.

NCT ID: NCT06326190 Not yet recruiting - Clinical trials for Recurrent Meningioma

177Lu-DOTATATE for Recurrent Meningioma

LUMEN-1
Start date: November 6, 2024
Phase: Phase 2
Study type: Interventional

Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand. The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using [177Lu]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with [177Lu]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate [177Lu]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.

NCT ID: NCT06275919 Not yet recruiting - Clinical trials for Meningioma, Malignant

Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)

MIRAGE
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III 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.

NCT ID: NCT06255249 Not yet recruiting - Meningioma Clinical Trials

Multicenter Evaluation in Patients With MEningiomas of the Response to Treatment With 177LUTEtium-oxodotreotide

MELUTE
Start date: July 30, 2024
Phase:
Study type: Observational

Meningiomas are the most common primary tumors of the central nervous system, representing more than a third of tumors.Current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory regardless of their grade. Some meningiomas express somatostatin type 2 receptors and can be treated with lutathera. This study aims to evaluate the response to treatment in this pathology

NCT ID: NCT06132685 Not yet recruiting - Meningioma Clinical Trials

Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial

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

This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.

NCT ID: NCT06126588 Not yet recruiting - Meningioma Clinical Trials

Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial

ELUMEN
Start date: October 1, 2024
Phase: Phase 2
Study type: Interventional

Meningioma, the most common intracranial primary tumor of the central nervous system predominantly affects people in their fifties. Meningiomas are generally subdivided into two entities: a priori non-aggressive meningiomas (grade 1), and meningiomas at high risk of aggressive behavior (grade 2/atypical and 3/anaplastic). The current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory irrespectively of grade, and in these rare entities, the therapeutic arsenal is reduced to the few treatments that have shown limited efficacy. Refractory, and particularly grades 2 and 3 meningiomas, have very poor prognoses with a progression-free survival at 6 months (PFS-6) of 26%. The European Response Assessment in Neuro-Oncology group (RANO) recommends that in any new, grades 2 and 3 meningioma, therapy that achieves a PFS-6 >30% in phase II trials be considered promising. In Nuclear Medicine, Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE, currently used on a compassionate basis in refractory meningioma, deploys an octreotide-like effect, and appears very promising, with preliminary PFS-6 of 94% and an overall survival at 12 months (OS-12) of 88% in grade 1 meningioma. However, its PFS-6 is reduced to 28% with an OS-12 of 65% in WHO grades 2 and 3 meningioma. Recently the non-radiolabeled octreotide and everolimus combination however achieved a PFS-6 of 55% and an OS-12 of 75% in a population of 90% WHO grades 2 and 3 meningioma.

NCT ID: NCT06012929 Not yet recruiting - Meningioma Clinical Trials

A Study of ONC201 for Refractory Meningioma

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about treatment for a type of brain tumor called a meningioma. This study will enroll two groups of people. One group will be for people who will receive surgery to remove their brain tumor. The other group will be for people who have previously received treatment for their brain tumor but do not have any other available options for treatment. The primary goals of this study are: 1. To measure how much of the study drug is present in tumor tissue taken from patients during surgery to remove their brain tumor 2. To measure the length of time between a study participant's first dose of study treatment until the time when their brain tumor gets worse or their death