Choroid Plexus Tumor

Researchers are evaluating the use of 18F-Fluciclovine positron emission tomography PET as a biomarker to measure the response or progression of brain metastasis in participants treated with stereotactic radiosurgery SRS. This pilot imaging study focuses on adults diagnosed with brain metastases who are planned to receive SRS treatment. The study is sponsored by Baptist Health South Florida and is a Phase 1 clinical trial. Participants will undergo an 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging MRI. They will then receive a single dose of SRS as part of their standard care. A second 18F-fluciclovine PET scan will be performed approximately 8 weeks after the SRS treatment, with a window of plus or minus 2 weeks. During PET scans, participants receive a 5-mCi dose of 18F-fluciclovine through intravenous injection, with imaging data collected up to 25 minutes post-injection. Throughout the study, participants will be monitored using PET imaging to evaluate changes in standardized uptake values SUV over 8 weeks, which helps assess tumor response. Tumor control will also be evaluated at 12 months. The study involves standard imaging, including MRI and PET scans, and tracks participant safety and treatment progress. Total participation timelines include initial scans at SRS planning and follow-up imaging about 8 weeks later, with tumor control assessed after one year.

Researchers are evaluating the use of Gallium-68-DOTATATE PETMRI in patients with somatostatin receptor-positive SSTR-positive central nervous system CNS tumors, mainly focusing on meningioma but also including other tumor types such as esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain. The study aims to assess the diagnostic usefulness of this imaging technique, especially in distinguishing tumor recurrence from post-treatment changes, with a particular interest in cases where tumor location limits surgical removal or where patients have higher-grade disease or previous radiation treatment. This is a Phase 4 interventional study sponsored by Weill Medical College of Cornell University.

Researchers are investigating the safety and effectiveness of Bevacizumab BEV with or without microbubble-mediated focused ultrasound FUS using the NaviFUS System in patients with recurrent glioblastoma multiforme rGBM. This pivotal, randomized, open-label study compares standard care BEV alone to BEV combined with FUS in patients who have previously undergone surgery, radiotherapy, and chemotherapy with temozolomide. BEV is considered the best current treatment choice for these patients after prior therapies. Participants will be randomly assigned to one of two groups. One group will receive BEV alone via intravenous infusion at a dose of 10 mgkg over 30-90 minutes every two weeks. The other group will receive the same BEV treatment followed by administration of microbubbles SonoVue at 0.1 mLkg and focused ultrasound exposure controlled by the NaviFUS System. Treatments will continue every two weeks for up to 34 weeks or until disease progression, intolerable side effects, non-compliance, or withdrawal. During the study, participants will be monitored through regular assessments including MRI scans, quality of life questionnaires, cognitive tests Mini-Mental State Examination, and evaluation of corticosteroid use and adverse events. The primary outcome is progression-free survival at six months. Secondary outcomes include survival rates up to two years, tumor response, local disease control, and performance status. The total study participation can last up to 36 months with ongoing safety and efficacy monitoring.

Researchers are evaluating whether mirdametinib is a safe and effective treatment for Central Nervous System tumors, including glioma and neurohistiocytosis. This phase 12 trial focuses on patients with MAPK pathway mutant CNS tumors to better understand the drugs impact on these conditions. The study is sponsored by Memorial Sloan Kettering Cancer Center and aims to measure the best overall neurologic response rate within one year. Participants are divided into two main groups. Eleven patients with refractory neurohistiocytosis will receive continuous cycles of mirdametinib. Meanwhile, 30 participants with recurrent NF1-mutant glioma will be randomized in a 21 ratio to either receive perioperative mirdametinib for five days before surgery or no drug before surgery. After surgery, all glioma participants will take mirdametinib twice daily continuously until disease progression or clinical changes occur. During the study, participants will undergo regular evaluations including neurological assessments and monitoring of disease progression via imaging scans. Researchers will collect data on safety, tolerability, and treatment response. The study includes scheduled visits, laboratory tests, and performance status assessments. Participation will continue until disease progression or other criteria require stopping treatment, with ongoing monitoring throughout the trial period.

Researchers are evaluating repotrectinib, an oral drug, in pediatric and young adult patients with advanced or metastatic cancers that have specific genetic changes in ALK, ROS1, or NTRK1-3 genes. The study includes two phases Phase 1 focuses on finding safe dose levels and the recommended dose for children under 12, while Phase 2 assesses the drugs anti-tumor activity in patients aged 12 to 25 with certain gene fusions or alterations. This study aims to address cancers that have progressed despite other treatments or have no standard cure options. In Phase 1, about 12 children under 12 years old with advanced solid tumors or lymphoma will receive different doses of repotrectinib to determine safety and the best dosing. Phase 2 includes three groups of patients aged 12 to 25, with varying genetic profiles and prior treatment histories, all receiving oral repotrectinib. The drug will be given continuously in cycles, with careful monitoring. Enrollment for Phase 1 and Phase 2 occurs simultaneously, allowing younger children to join Phase 2 once their dose is established. Participants will undergo regular assessments including scans and tests to measure tumor response, drug levels in the blood, and side effects. The study tracks several outcomes such as response rate, duration of response, survival, and brain tumor progression over approximately three years. Safety and tolerability are closely monitored during the first 28 days of treatment, with ongoing follow-up visits throughout the study period. This long-term observation helps researchers understand both the drugs effects and patient well-being.

Researchers are evaluating the safety and effects of PF-07799544 alone or combined with PF-07799933 as a potential treatment for adults with advanced solid tumors that have a BRAF V600 mutation. This phase 1ab open-label study is focused on patients with metastatic or recurrent solid tumors, excluding colorectal cancer. The trial includes two parts phase 1a studying PF-07799544 alone and phase 1b studying the combination of both drugs. Phase 1a enrollment is closed, while phase 1b is actively seeking participants. In this study, all participants receive both PF-07799544 and PF-07799933 as oral tablets taken at home twice daily. Treatment continues until cancer progression, unacceptable side effects, or a maximum of two years, with the option to extend therapy beyond two years. The study aims to understand patient experiences with these medicines and to determine their safety and effects. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, lab abnormalities, vital signs, and physical exams from baseline through the treatment period and up to 28 days after the last dose. The primary outcome evaluates overall response rate during the two-year treatment. Additional pharmacokinetic data and long-term safety are also collected. The total participation duration may extend up to two years or longer if treatment continues.

Researchers are evaluating a new method to better understand how brain stimulation during awake craniotomies affects hand strength and function in patients with brain tumors invading the primary motor cortex. The study aims to improve the current standard of care, which involves brain surgery with electrical stimulation mapping to avoid permanent neurological damage. Investigators want to develop a standardized way to measure hand movement and explore different stimulation settings to see how they influence motor mapping. Participants will undergo awake craniotomy surgery where additional brain stimulation procedures with varying parameters will be tested beyond the usual care. This will help assess changes in hand strength and movement during the operation. The study focuses on patients with tumors affecting the non-dominant side of the brains motor cortex. The intervention involves direct electrical stimulation applied during surgery to map motor function. During the study, participants will have their hand strength and function quantitatively measured while surgeons apply different stimulation settings. Researchers will monitor how these parameters interrupt or facilitate hand movement. Data collected will include motor strength assessments and functional tests during surgery to better understand brain stimulation effects. The study includes careful monitoring of neurological function throughout the procedure and will track outcomes related to hand movement during the craniotomy.

Researchers are studying patients with recurrent glioblastoma or progressive high-grade astrocytoma who are scheduled for repeat surgery. This Phase I trial aims to find the highest safe dose of a modified oncolytic adenovirus given with fractionated stereotactic radiosurgery in these patients. The study combines gene therapy with radiation to evaluate potential treatment options for these brain tumors. Participants will receive a single injection of the Ad5-yCDmutTKSR39rep-ADP adenovirus directly into the tumor area after surgery, at one of three increasing dose levels. This gene therapy is combined with oral medications 5-fluorocytosine and valganciclovir, followed by fractionated stereotactic radiosurgery. Treatment continues until unacceptable side effects, tumor progression, or withdrawal. The study includes a monitoring period before starting any new cancer therapy. During the study, patients will be closely monitored for safety and immune response through blood tests and assessments at multiple time points before and after surgery, up to 90 days. Researchers will measure the maximum tolerated dose and observe changes in immune markers. The study lasts through treatment and follow-up, with a 30-day observation before other therapies begin, ensuring comprehensive safety and response evaluation.

Researchers are building a large-scale MRI database focused on malignant brain tumors, including gliomas, brain metastases, and lymphomas. The study aims to develop an artificial intelligence AI system using deep learning to segment and classify multiple brain tumor subtypes. This approach seeks to improve non-invasive preoperative diagnosis accuracy and reduce the need for biopsies, addressing limitations in current methods due to small sample sizes and limited classification performance. The study collects retrospective data from two main centers, gathering 3,000 cases confirmed by histopathology with preoperative multimodal MRI scans, mainly CE-T1WI and T2-FLAIR images taken on 3.0T or 1.5T MRI machines. The AI system is designed to automatically segment complex tumor tissues and assist in diagnosing common malignant brain tumors. This deep learning-based diagnostic tool aims to enhance the accuracy of brain tumor classification and support clinical decision-making. Participants MRI images and pathology results are used to build the AI-assisted diagnostic system within 30 days. The study involves reviewing and analyzing imaging data retrospectively without active treatment. Researchers focus on constructing and validating the AI system to improve auxiliary diagnosis for brain malignancies. The total participation involves providing access to imaging and diagnostic information, with no additional procedures required from patients.

Researchers are evaluating how well pafolacianine works to identify cancerous lesions in children and adolescents with primary or metastatic solid tumors. This phase III trial focuses on using pafolacianine, a fluorescent imaging agent that targets folate receptors often found in many cancers. The agent is combined with near infrared NIR imaging during surgery to help locate tumor cells more effectively in pediatric patients with solid tumors. Participants receive an intravenous infusion of pafolacianine over 60 to 90 minutes before undergoing NIR fluorescent imaging during their planned standard of care surgery. During surgery, tissue samples are collected for analysis. This study involves only one experimental group using pafolacianine combined with NIR imaging to assist tumor detection during surgery. Throughout the trial, researchers monitor the accuracy of pafolacianine with NIR imaging in detecting lesions up to 30 days after surgery. They also measure the time between pafolacianine administration and imaging detection, reasons for not removing certain lesions, and any adverse events related to surgery. Participants are closely followed to assess safety and effectiveness of this imaging method as part of their surgical care.