Ependymoma

Researchers are evaluating the optimization of 18F-DOPA PET/CT 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 Parkinson's disease or Lewy body dementia. The study aims to improve image quality using a new digital PET/CT 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 PET/CT 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 PET/MRI 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 PET/CT scans in patients with breast, brain, and prostate cancers that express specific receptors (GRPR and integrin αvβ3). 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 PET/CT 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 MBq/kg. 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 PET/CT 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 the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

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 software's 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 drug's 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 treatment's effects over time.

Researchers are evaluating whether sitagliptin, an investigational drug, can improve the immune response against glioblastoma by targeting myeloid-derived suppressor cells (MDSCs), which suppress the body's natural defense against cancer. Glioblastoma patients have increased MDSCs, and reducing these cells may help reverse immunosuppression. This phase 2 study focuses on patients with progressive grade 4 gliomas who are undergoing surgery and chemotherapy. The investigation builds on prior findings that MDSCs rely on an enzyme called DPP-4, which sitagliptin inhibits. Participants will be divided into two groups: one will receive presurgical sitagliptin followed by post-surgical sitagliptin and chemotherapy, and the other will start sitagliptin only after surgery along with chemotherapy. Sitagliptin is taken orally at doses ranging from 25 mg to 100 mg daily, self-administered by participants. The study includes a "window of opportunity" period before surgery to assess the drug's biological impact, followed by ongoing treatment until disease progression. During the study, participants will undergo tumor resection surgery and receive laboratory tests to monitor organ function and blood counts. Researchers will measure immune cell changes in tumor tissue, focusing on CD8+ T cells, and track progression-free and overall survival at specified intervals. Safety will be assessed by recording adverse events up to 30 days after treatment ends. The total duration of participation varies depending on individual treatment response and disease progression.

Diffuse gliomas are tumors affecting the brain and spinal cord, especially aggressive in people with mutations in the IDH1 or IDH2 genes. This trial evaluates zotiraciclib, a study drug being tested for effectiveness in people aged 15 and older with recurrent diffuse gliomas that have these gene mutations. The research includes a phase I/II design to assess safety, dosing, and how well the drug works compared to existing data. Participants will take zotiraciclib capsules by mouth on specific days (1, 4, 8, 11, 15, and 18) during 28-day treatment cycles, for up to 18 cycles. Dose levels may be adjusted based on tolerance, and some participants undergoing surgery will receive a single pre-treatment dose before tumor biopsy or removal. The study includes different groups, including dose escalation, recommended dose estimation, and a surgical cohort. Before joining, participants will have physical exams, blood and urine tests, heart function tests, and brain MRIs. They will keep medication diaries to track dosing. Clinic visits occur about once a month for exams and tests, with brain MRI scans every 8 weeks. Researchers will monitor progression-free survival over 12 months and evaluate safety and longer-term outcomes. Total participation may last up to 1.5 years or 18 treatment cycles.

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.