Schwannoma

Researchers are evaluating the optimization of 18F-DOPA PETCT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinsons disease or Lewy body dementia. The study aims to improve image quality using a new digital PETCT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PETCT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

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 evaluating a new dual-target imaging agent called 68Ga-RM26-RGD for PETCT scans in patients with breast, brain, and prostate cancers that express specific receptors GRPR and integrin v3. This study aims to improve tumor detection by comparing this agent with conventional 18F-FDG and single-target imaging agents, addressing limitations of current imaging methods in detecting tumors with low 18F-FDG uptake or variable receptor expression. Participants will undergo PETCT scans using intravenous injections of 68Ga-RM26-RGD and one of the comparator agents 18F-FDG, 68Ga-RM26, or 68Ga-RGD within a two-week period. The dosages for these agents are approximately 1.8-2.2 MBqkg. Each patient receives scans with both agents to compare imaging performance directly. During the study, researchers will assess diagnostic accuracy and dosimetry of 68Ga-RM26-RGD over about one year. Participants will have multiple PETCT scans and related evaluations to monitor uptake of the imaging agents in tumors. The study includes safety and diagnostic performance monitoring throughout the participation period.

Researchers are evaluating a new clinical fMRI software designed to map critical brain functional networks and cerebrovascular reactivity in patients with brain tumors. The goal is to improve presurgical planning by integrating resting-state fMRI rs-fMRI, task-based fMRI tb-fMRI, and cerebrovascular reactivity CVR mapping. This observational study aims to validate the accuracy of rs-fMRI compared to tb-fMRI using intra-operative direct cortical stimulation as the gold standard, and to test whether CVR mapping enhances confidence in identifying important brain areas. The study involves developing and optimizing software to map resting-state networks and CVR, then testing its use in patients undergoing neurosurgical tumor removal. The research includes retrospective review of prior clinical presurgical fMRI studies and a prospective phase where patients will have presurgical fMRI and direct cortical stimulation as part of their standard care. The software development will be done in partnership with a commercial MRI software producer to create robust clinical tools. Participants will undergo presurgical fMRI scans, including resting-state and task-based imaging, as part of their usual care, followed by direct cortical stimulation during surgery. Researchers will analyze these imaging data to validate the softwares mapping accuracy. The primary outcome is to confirm the ability of rs-fMRI to identify language and motor areas reliably. The study will continue through to completion, averaging about one year per participant, with no investigational treatments given, focusing on imaging and surgical assessments.

Researchers are studying patients with progressive grade 4 gliomas, specifically glioblastoma, to see if the drug sitagliptin can enhance the immune systems response against the tumor. This study focuses on how sitagliptin might affect myeloid-derived suppressor cells MDSCs, which suppress the bodys natural defense against cancer. The trial builds on previous findings showing that reducing MDSCs may improve immune activity in glioblastoma patients. Participants will be divided into two groups one receiving sitagliptin before and after tumor surgery, and the other receiving sitagliptin only after surgery. Sitagliptin will be self-administered orally at varying doses 100 mg, 50 mg, or 25 mg daily. Following surgery, all participants will also receive chemotherapy until their disease progresses. The study is designed as a randomized, phase 2 trial to investigate the safety and biological impact of sitagliptin treatment. During the study, participants will undergo tumor surgery and receive sitagliptin treatment. Researchers will measure immune cell levels in the tumor tissue and track survival rates and disease progression. Safety will be monitored by recording any adverse events up to 30 days after treatment ends or until death. The primary outcome focuses on differences in tumor immune cells right after surgery, with follow-up evaluations up to 12 months. Participation may last until disease progression or study end, with ongoing monitoring throughout.

Researchers are investigating zotiraciclib, an oral multi-kinase inhibitor, in people aged 15 years and older with recurrent diffuse gliomas that have mutations in the IDH1 or IDH2 genes. These gliomas are aggressive brain and spinal cord tumors that return after prior treatments such as radiation or chemotherapy. This phase III study aims to determine the recommended dose and evaluate the effectiveness of zotiraciclib in this patient group. Participants will take zotiraciclib capsules by mouth on specific days 1, 4, 8, 11, 15, and 18 during 28-day cycles for up to 18 cycles about 1.5 years. Dose levels may be adjusted depending on tolerance, with some participants undergoing surgery and receiving a single dose before tumor biopsy or resection. The study includes several groups based on dose escalation and surgical status. During the study, participants will visit the clinic roughly once a month for physical exams, blood and urine tests, heart function evaluations, and brain MRIs every 8 weeks. They will keep a medication diary to track their doses. Researchers will monitor safety, measure progression-free survival, and assess overall survival over multiple years. The total study participation may last up to 18 cycles of treatment.

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.

Spinal cord gliomas are rare malignant tumors that develop within the spinal cord, often appearing around age 35 and slightly more common in males. These tumors typically cause symptoms like axial pain and tend to grow in a lateral, infiltrative pattern. Treatments are limited mainly to surgery, and the choice of surgical approach can affect neurological outcomes and quality of life. This research compares two surgical methods to find the best approach for tumor removal and patient recovery. The study compares the dorsolateral sulcus DLS approach and the traditional posterior median sulcus PMS approach for spinal cord tumor removal. The DLS approach is thought to better preserve neurological function by avoiding critical midline structures, while the PMS approach offers direct midline access but risks more damage. Patients with laterally located tumors, confirmed by imaging and pathology, undergo surgery via one of these two methods. Outcomes will be assessed over time to evaluate pain, neurological function, quality of life, tumor removal extent, and survival. Participants will be evaluated before surgery and followed up at 1, 3, 6, and 12 months after surgery with clinical exams, imaging, and questionnaires like the Visual Analog Scale for pain and SF-36 for quality of life. Neurological function is measured using established grading scales, and tumor progression and survival are monitored up to 24 and 36 months, respectively. The study aims to determine which surgical approach best balances effective tumor removal with preservation of neurological health.

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 the effectiveness of sotorasib in treating brain tumors that have the KRAS G12C mutation. This study aims to understand how well sotorasib reaches these metastatic brain tumors during surgical removal, and to assess the safety and effectiveness of the treatment. Additionally, the study will examine how the body absorbs, distributes, and eliminates sotorasib. Participants will receive sotorasib either at the standard FDA-recommended dose or continue with their current dose as directed by their doctor. The study includes adults undergoing neurosurgical resection or biopsy of one or more brain tumors, including those with leptomeningeal metastasis if they require brain tumor surgery. There is no limit on previous radiation or systemic therapy, and treatment will follow standard care guidelines. During the study, participants will have assessments of tumor response over the course of one year, including monitoring of overall response rate. Safety and treatment effects will be closely observed through regular clinical evaluations and laboratory tests to measure blood counts, kidney and liver function, and other health parameters. The trial is non-randomized and open-label, with the Memorial Sloan Kettering Cancer Center leading the study, and participation will last as long as the treatment and follow-up periods extend.