Ependymoma

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 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 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 evaluating the use of the drug SGT-53 in combination with radiation therapy and the drug Nivolumab in children with brain tumors that have returned, worsened, or not improved after previous treatments. This early-phase clinical trial aims to find the right dose of SGT-53 that can be safely given alongside radiation and Nivolumab. The study also investigates the side effects of SGT-53, how the drug moves through the body, and how much of it reaches the tumor tissue in a small group of patients. During the first treatment cycle, participants receive SGT-53 twice a week, Nivolumab every two weeks, and radiation therapy during the second week. In cycles two through six, SGT-53 is given once a week during even cycles and twice a week during odd cycles, while Nivolumab continues every two weeks. From cycle seven onward, both SGT-53 and Nivolumab are given every two weeks. In a special early part of the study, four participants will have genetic testing on tumor samples after receiving SGT-53 to compare with skin samples. Participants will be closely monitored throughout the study with evaluations of side effects related to SGT-53 from enrollment to three years after treatment ends. Researchers will assess the drugs safety, how it is processed in the body, and its presence in tumor tissue. The study includes clinical and radiological assessments, genetic testing, and ongoing safety monitoring to understand the treatments effects over time.

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 evaluating the use of a bioresorbable bone adhesive called Tetranite for improving cranial flap fixation in patients undergoing craniotomy. This pilot clinical study aims to demonstrate the safety and effectiveness of Tetranite compared to current metal fixation methods, with assessments at the time of fixation and after six months. The study focuses on safety outcomes and patient-reported results to support further clinical studies involving more patients. Participants will receive cranial flap fixation using either the standard metal plates and screws with Tetranite applied to fill kerf lines and burr holes, or Tetranite alone for flap fixation. The study includes two groups the first five patients will have metal fixation plus Tetranite augmentation, followed by patients receiving only Tetranite. Treatments are delivered during surgery, with follow-up evaluations extending to twelve months. Participants will be monitored through clinical assessments including CT imaging to evaluate bone healing and flap position, clinical palpation to check flap immobility, and patient surveys measuring pain and quality of life. The primary safety outcome is the rate of serious device or procedure-related adverse effects within six months. Secondary measures include radiolucency changes, device-related events, flap translation, and patient-reported outcomes over a one-year period. The total participation time includes surgery and follow-up visits for up to twelve months.

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.