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Brain Neoplasms clinical trials

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NCT ID: NCT06048094 Recruiting - Brain Metastases Clinical Trials

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

FACILITATE
Start date: April 11, 2024
Phase: Phase 1
Study type: Interventional

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

NCT ID: NCT06047379 Recruiting - Colorectal Cancer Clinical Trials

Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

Start date: November 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled brain metastasis. The study will have three phases, Phase 1, Phase 2a and Phase 2b.

NCT ID: NCT06045065 Recruiting - Brain Metastases Clinical Trials

Preclinical Brain Tumor Models

HITCH
Start date: January 2, 2022
Phase:
Study type: Observational

Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies. In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic. Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples. Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R). Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.

NCT ID: NCT06038760 Recruiting - Glioblastoma Clinical Trials

Prospective Evaluation of AI R&D Tool in Adult Glioma and Other Primary Brain Tumours (PEAR-GLIO)

PEAR-GLIO
Start date: October 12, 2023
Phase:
Study type: Observational

Pear Bio has developed a 3D microtumor assay and computer vision pipeline through which the response of an individual patient's tumor to different anti-cancer regimens can be tested simultaneously ex vivo. This study will recruit patients with primary brain tumors who are due to undergo surgery. Oncologists will be blinded to treatment response on the Pear Bio tool (the assay will be run in parallel with the patient's treatment). The primary objective of this study is to establish the ex vivo model and confirm whether approved therapies exhibit their intended mechanism of action in the model. Secondary objectives include correlating test results to patient outcomes, where available.

NCT ID: NCT06029140 Recruiting - Clinical trials for Brain Metastases, Adult

Stereotactic Radiotherapy Management of Brain Metastases: the Value of a Longitudinal Multimodal Approach (POSTPONE)

POSTPONE
Start date: August 1, 2023
Phase:
Study type: Observational

The management of brain metastases has evolvedĖ rapidly in recent years. It is estimated that 20% to 40% of cancer patients will develop brain metastases (BM) during the course of their disease. Whole-brain radiotherapy has long been the first-line treatment for brain metastases. However, large-scale international clinical trials conducted over the past decade have established stereotactic radiotherapy (SR) as the treatment of choice for the management of brain metastases (BM). However, even though the method of radiation delivery has evolved considerably, the problem of monitoring and managing brain metastases remains unresolved. This study therefore has several focuses: 1. Evaluation of the benefit of early remnographic assessment (6 weeks): impact on recurrence-free survival and overall survival. 2. Evaluation of a diagnostic approach to radionecrosis: complementarity of DOPA PET and multimodal MRI. 3. The benefits of longitudinal remnographic monitoring with the development of segmentation and automated follow-up tools

NCT ID: NCT06020066 Recruiting - Clinical trials for Non-small Cell Lung Cancer

SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

Start date: August 10, 2023
Phase: Phase 2
Study type: Interventional

Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.

NCT ID: NCT06014450 Recruiting - Clinical trials for Prophylactic Cranial Irradiation, Cumulative Incidence of Brain Metastases

Prophylactic Cranial Irradiation Versus Observation in Stage IV NSCLC Randomized Controlled Clinical Study

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

Lung cancer has remained the leading cause of cancer-related deaths worldwide. An important and frequent cause of morbidity in this patient group is the development of brain metastases (BM). Lung cancer represents the leading cause of BM, and previous reports have shown that approximately 40% of patients will develop BM throughout their disease. Additionally, due to the improved use of advanced imaging techniques as part of routine initial staging. Another factor to consider is the considerably prolonged survival in patients with lung cancer as a direct result of the medical advances that have improved systemic disease control in the past 2 decades. The development of BM has recognized as one of the most detrimental factors for patient prognosis, with a negative impact on quality of life (QoL), concomitant neurocognitive disorders, and, importantly, a significant decrease in OS. RTOG 0214 shows that In patients with stage III disease without progression of disease after therapy, PCI decreased the rate of BM. NVALT-11/DLCRG-02 Study shows that PCI significantly decreased the proportion of patients who developed symptomatic brain metastases with an increase in low-grade toxicity. In conclusion, PCI improved DFS and decreased the risk of BM in patients with LA-NSCLC.Recent studies suggest NSCLC, including stage IV NSCLC, PCI significantly decreased CBM in addition to increasing progression-free survival and OS. At present, few studies on whether prophylactic radiation therapy can reduce the rate of brain metastasis and OS in stage IV NSCLC. In this randomized controlled study of stage IV NSCLC, we investigated whether PCI reduces the chance of brain metastases and whether it has a survival benefit.

NCT ID: NCT06012695 Recruiting - Malignant Neoplasm Clinical Trials

NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma

Start date: August 11, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

NBM-BMX is an orally available new chemical entity to inhibit histone deacetylases 8 (HDAC8) activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. This study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors or combination with the standard of care treatment in subjects with newly diagnosed glioblastoma.

NCT ID: NCT05996432 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy

Start date: May 17, 2023
Phase: Early Phase 1
Study type: Interventional

This study will apply novel MRI approaches with established sensitivity to tissue oxygen consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as tumor recurrence and progression post-treatment.

NCT ID: NCT05987644 Recruiting - Lung Cancer Clinical Trials

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

DURABLE
Start date: March 7, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib. A maximum of 25 cycles (2 years) of alectinib may be administered on study.