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Brain Neoplasms clinical trials

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NCT ID: NCT06243003 Recruiting - Brain Metastases Clinical Trials

WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases

Start date: January 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS as first-line treatment for SCLC patients with brain metastases.

NCT ID: NCT06238882 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Nitroglycerin Plus Radiotherapy Versus Conventional Radiotherapy in Patients With Lung Cancer.

Start date: February 23, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional phase III clinical trial is to evaluate objective intracranial response rate (iORR) after a treatment with total cranial radiation therapy plus concomitant transdermal nitroglycerin (NTG) addition or total cranial radiation therapy only in patients with stage IV non-small cell lung cancer with brain metastases and EGFR mutation. The main questions it aims to answer are: Determine progression-free survival (PFS) to CNS and overall survival (OS). Evaluate and compare the quality of life (QoL) of patients during and after treatment. Evaluate the cognitive function of patients before, during and after treatment. Evaluate treatment-associated toxicity to grade adverse treatment events Evaluation of HIF1α, VEGF and ROS1 in peripheral blood before and after nitroglycerin treatment. All participants will have laboratory tests at the beginning and end of radiation therapy. Cranial MRI will be performed prior to treatment and 12 weeks after the end of treatment, then every 16 weeks until intracranial progression. Patients in the interventional group will be given 36 mg patches of transdermal nitroglycerin for 24 hours with a 12-hour rest interval during treatment with radiation therapy. The control group will only receive total cranial radiation therapy at the same doses and with the same schedule.

NCT ID: NCT06231186 Recruiting - Clinical trials for Brain Metastases, Adult

a Feasibility Study of iHD-SRT for BM

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

Brain metastasis is the most challenging disease in the field of tumor treatment, with a median overall survival of only 1-2 months for untreated patients. Stereotactic radiotherapy (SRT) has the advantages of precise positioning, relatively concentrated dosage, shorter course, and lower toxicity. Several studies could effectively protect cognitive function and achieve better tumor control rate. Currently, it has gradually replaced WBRT as standard local treatment choice for brain metastases. SRT includes Stereotactic Radiosurgery (SRS) and Fractional Stereotactic Radiotherapy (fSRT). With the continuous updating of domestic radiation therapy equipment, the use of high-resolution multi leaf gratings enables the accuracy of fSRT based on linear accelerators to reach 0.5mm or even lower levels, and has gradually become one of the main choices for local treatment of a limited number of patients with brain metastases. However, there is currently no prospective randomized controlled study data analyzing the clinical benefits of different segmentation and dosages of SRT. In retrospective data comparing different segmentation schemes, researchers found that higher BED was associated with better local control. However, the ASTRO guidelines recommend relatively conservative doses for SRT of brain metastases, especially as the lesion volume increases, and the recommended dose of BED10 for SRT was only 48 Gy (30 Gy/5 Fx). This is based on the consideration that higher radiation exposure will bring a higher risk of radiation-induced brain necrosis. However, with the continuous updates of SRT treatment equipment and technology, existing technologies can achieve higher dose coverage for more brain metastases while meeting the normal tissue limit. Therefore, this study conducted a prospective intervention study to explore the feasibility and safety of optimizing SRT dosage based on normal tissue tolerance for the treatment of brain metastases, in order to further improve the therapeutic effect of intracranial lesions with brain metastases. This study is designed as a single arm open prospective study, assuming that under this treatment regimen, the proportion of patients with lesion prescription dose BED10>50 Gy is 90%, and the incidence of radiation-induced brain necrosis within 1 year is 8.5%. The planned enrollment period is 2 years and follow-up period is 1 year. A total of 35 people need to be enrolled.

NCT ID: NCT06209567 Recruiting - Brain Metastases Clinical Trials

A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors

Start date: January 5, 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.

NCT ID: NCT06194929 Recruiting - Melanoma Clinical Trials

Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

DETERMINE
Start date: February 8, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this interventional clinical trial is to provide proof-of-principle data for the biologic activity of defactinib in combination with avutometinib in brain metastases from melanoma, and to define the potential role of the combination with mutant BRAF inhibitors or after BRAF/MEK inhibitors in BRAF V600E/K mutant tumors, in individuals with advanced melanoma who experience the development or progression of brain metastases after treatment with immune checkpoint inhibitors. The main questions it aims to answer are: - What is the preliminary response rate of defactinib and avutometinib in patients with RAS mutant, BRAF mutant, NF1 mutant, triple RAS/BRAF/NF1 wild type (wt) melanoma (including RAF fusions)? - What is the safety and tolerability of the combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E/K mutant melanoma with at least one untreated brain metastases? - What is the preliminary response rate of the three drug combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E/K mutant melanoma.

NCT ID: NCT06180460 Recruiting - Clinical trials for Metastatic Breast Cancer

CALM: Managing Distress in Malignant Brain Cancer

Start date: November 10, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.

NCT ID: NCT06176261 Recruiting - Breast Cancer Clinical Trials

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Start date: December 26, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)

NCT ID: NCT06165653 Recruiting - Brain Neoplasms Clinical Trials

Guided Meditation During Radiation Therapy for Brain Tumors

Med-RT
Start date: February 29, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors. The main question it aims to answer is: • What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions? Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.

NCT ID: NCT06159335 Recruiting - Radiation Therapy Clinical Trials

18F-FLUC-CEST PET/MR in Patients With Brain Mets

Start date: January 10, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to use new imaging methods to help in finding out whether the imaging shows that there is a tumor in people with a brain metastasis. The main question it aims to answer is whether positron emission tomography (PET) and magnetic resonance imaging (MRI) find cancerous tissue better than other types of imagining. Participants will undergo a single PET/MRI scan, followed by a separate MRI scan with a tracer. Study participation will last about 3 hours.

NCT ID: NCT06152822 Recruiting - Clinical trials for Breast Cancer With Brain Metastases

Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases

Start date: November 30, 2023
Phase: Phase 2
Study type: Interventional

This study intends to conduct a small, prospective, single-center clinical study to explore and evaluate the efficacy and safety of pyrrotinib combined with capecitabine and bevacizumab in HER2-positive advanced breast cancer with brain metastases.The overall objective is to provide a new drug regimen for HER2 positive breast cancer patients with brain metastases by balancing survival benefits and patient quality of life.