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Brain Neoplasms clinical trials

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NCT ID: NCT05342454 Recruiting - Brain Tumor Clinical Trials

A Comprehensive Clinical fMRI Software Solution to Enable Mapping of Critical Functional Networks and Cerebrovascular Reactivity in the Brain

Start date: May 23, 2022
Phase:
Study type: Observational

Our preliminary work demonstrates that an integrated fMRI software solution, incorporating tb-fMRI, rs-fMRI, and CVR mapping, is clinically feasible and helps clinicians plan brain tumor resection. We have developed a novel automated seed selection method that can accurately map language networks from rs-fMRI. We hypothesize that our innovative approach to enhance, optimize, and validate our preliminary software and integrate it with an established fMRI platform will create robust solutions for clinical RSN and CVR mapping. Partnering with NordicNeuroLab (NNL) will leverage the professional software development by a seasoned commercial MRI software producer in coordination with leading clinical and research experts at MD Anderson. The research will be conducted through three specific aims: 1. Develop a clinical software platform for mapping RSNs and determine optimized workflow for presurgical localization of eloquent areas. 2. Develop a clinical software platform for mapping CVR and determine optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results. 3. Test and validate RSN and CVR mapping software in patients undergoing neurosurgery.

NCT ID: NCT05341739 Recruiting - Clinical trials for Brain Metastases, Adult

A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

Start date: December 14, 2021
Phase: N/A
Study type: Interventional

This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.

NCT ID: NCT05341349 Recruiting - Metastatic Melanoma Clinical Trials

Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-100M for the Treatment of Melanoma Brain Metastases

Start date: October 13, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, 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. NovoTTF-100M is a portable battery operated device which produces tumor treating fields in the body by means of surface electrodes placed on the skin. Tumor treating fields are low intensity, intermediate frequency electric fields that pulse through the skin to disrupt cancer cells' ability to divide. Giving stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.

NCT ID: NCT05340881 Recruiting - Brain Tumor Clinical Trials

Systematic Light Exposure in Pediatric Brain Tumor Survivors

SLEPBT
Start date: October 14, 2022
Phase: N/A
Study type: Interventional

Children and adolescents treated for a brain tumor often experience fatigue and cognitive symptoms, such as slowed information processing and inattention. These symptoms may cause difficulty carrying out daily activities at home and at school. There are few well-researched, non-pharmacological interventions aimed at improving symptoms of fatigue and by extension cognitive symptoms. Systematic bright light exposure has been shown to improve symptoms of fatigue in adult survivors of cancer and children treated for some forms of cancer. This is a pilot/feasibility study and the first known study in children treated for a brain tumor. Findings from this study will be used to help plan a larger study to examine the effectiveness of this intervention and mechanisms of action. PRIMARY OBJECTIVE: 1. To evaluate feasibility and adherence in a study of systematic bright light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, adherence, and acceptability. SECONDARY OBJECTIVES: 2. To estimate the effect size of change in fatigue associated with bright light exposure. 3. To estimate the effect size of change in cognitive efficiency associated with bright light exposure.

NCT ID: NCT05326425 Recruiting - Lung Neoplasms Clinical Trials

Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.

Start date: June 23, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment. The objective of this study is as follows. - Primary objective : intracranial objective response rate (iORR) with RECIST 1.1 - Secondary objectives : intracranial progression free survival(iPFS), Intracranial objective response rate in T790M negative, isolated CNS progression patient group, overall Objective Rsponse Rate(ORR), duration of response(DoR), disease control rate(DCR), treatment failure pattern): intracranial progression or extracranial progression or both, salvage intracranial treatment rate, safety and tolerability

NCT ID: NCT05323955 Recruiting - Brain Metastases Clinical Trials

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

BRIDGET
Start date: March 23, 2023
Phase: Phase 2
Study type: Interventional

Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled. They will receive local therapy with stereotactic radiosurgery ± surgical resection if indicated followed by enrollment. Patients will continue standard of care trastuzumab/pertuzumab or T-DM1 with the addition of tucatinib. Hormone receptor positive patients requiring endocrine therapy should continue. Study treatment will continue until disease progression or intolerable side effects. Patients on trial with extracranial disease progression with stable intracranial disease should continue tucatinib into next line of therapy.

NCT ID: NCT05317858 Recruiting - Brain Tumor Clinical Trials

Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets

Start date: August 12, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy.

NCT ID: NCT05305365 Recruiting - Breast Cancer Clinical Trials

Study Assessing QBS72S For Treating Brain Metastases

Start date: August 16, 2022
Phase: Phase 2
Study type: Interventional

This study is to evaluate the efficacy and safety of QBS72S in participants with advanced, relapsed, metastatic breast cancer with CNS involvement.

NCT ID: NCT05298995 Recruiting - High Grade Glioma Clinical Trials

GD2-CAR T Cells for Pediatric Brain Tumours

Start date: November 9, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.

NCT ID: NCT05293197 Recruiting - Malignant Glioma Clinical Trials

Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients

SONOKID
Start date: February 6, 2023
Phase: Phase 1
Study type: Interventional

Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin. Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.