Meningioma

Researchers are investigating new treatment options for meningiomas that continue to grow despite local therapies like surgery or radiotherapy. This trial focuses on evaluating a precision medicine approach that combines PET-based imaging to select patients with tumors expressing somatostatin receptors and a targeted radioligand therapy called 177Lu-DOTATATE. This is the first randomized clinical trial studying this therapy in patients with meningiomas that have not responded to other treatments. Participants will be randomly assigned to one of two groups. One group receives 177Lu-DOTATATE through intravenous infusions every four weeks for a total of four cycles. The other group receives local standard care, which may include treatments like hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or observation with supportive care, based on the investigators choice. This study is designed to compare the effects of 177Lu-DOTATATE against various standard treatments in this patient population. During the study, participants will undergo regular MRI scans to measure tumor size and progression. Researchers will also assess overall survival, neurological function, quality of life, and treatment side effects over a period extending up to two years after enrollment. Monitoring includes imaging, laboratory tests, and health questionnaires to evaluate how the disease and treatments affect participants over time.

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 three-dimensional magnetic resonance elastography 3D MRE to measure tumor stiffness and adhesion in patients with meningioma scheduled for surgical removal. This study aims to see if 3D MRE can serve as a noninvasive imaging tool to help surgeons plan operations, assess risks, and predict tumor behavior by comparing MRE findings with what surgeons observe during surgery and with pathological analysis after surgery. Participants will receive standard brain MRI along with additional 3D MRE scans before surgery. The 3D MRE uses vibrations and special software to create maps showing tumor stiffness and adhesion, which are shared with the neurosurgical team. During surgery, doctors will record tumor texture, adhesion, blood supply, and difficulty of removal to compare with the MRE results. Participants involvement includes preoperative MRI and MRE scans, surgery with detailed recording of tumor characteristics, and postoperative pathological analysis of tumor samples. Researchers will analyze how well MRE measurements match the surgical and histological findings. The main outcome is measuring agreement between MRE stiffness and tumor texture observed during surgery. The study is expected to continue until 2027, involving about 300 participants aged 18 to 80 years.

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.

There is no clear agreement on the best way to treat cystic lesions in the pituitary and surrounding areas, which are rare and challenging to manage. Traditional treatments like surgery or radiation often cannot fully remove or treat the cyst wall without serious risks. This research evaluates the use of stereotactic intracavitary instillation of 90yttrium colloid as a possible treatment option for these cystic sellar and parasellar tumors, aiming to find a safer and effective approach. The experimental treatment involves inserting 90yttrium colloid directly into the cystic cavity of the tumor during surgery. The neurosurgeon will decide the specific surgical approach based on individual patient needs, which will be described in the surgical consent. This procedure is compared to standard surgical care, and patients are monitored closely after treatment. Participants will undergo surgery as part of standard care, followed by monitoring for cyst shrinkage at 12 months after treatment. Imaging with PET-CT will be used within three weeks of treatment to locate the 90yttrium colloid. Researchers will track clinical and radiological stability, neurological function, and tumor response throughout the study, which may last several years until 2031.

Researchers are evaluating a new dual-targeting molecular probe called 68Ga-TATE-RGD for imaging tumors that express somatostatin receptor 2 SSTR2 and integrin 23. This study focuses on patients with tumors such as small cell lung cancer, pulmonary carcinoid, medullary thyroid cancer, and neuroendocrine tumors NETs that show positive expression of these receptors. The goal is to improve tumor detection and explore potential therapeutic uses of this dual-target tracer compared to existing single-target tracers. Participants will receive intravenous injections of the imaging agents 68Ga-TATE-RGD and 18F-FDG at specified doses for PETCT and SPECTCT scans. About 30 patients with confirmed positive expression of SSTR2 and integrin 23 will undergo imaging to assess the tracers ability to detect tumors. The study is conducted under an early phase 1 protocol with no masking or blinding. During the study, patients will undergo PETCT and SPECTCT imaging within a week using the tracers. Researchers will measure tumor detection rates and standardized uptake values SUV over an average follow-up of half a year. Assessments include imaging evaluations and monitoring for any medical conditions affecting compliance. The total duration of participation varies but includes imaging and follow-up to evaluate diagnostic performance and tracer kinetics.

Researchers are evaluating the safety and feasibility of using the ExAblate 4000 system to treat benign centrally-located intracranial tumors in children and young adults who need clinical intervention. This prospective, non-randomized, single-arm feasibility study focuses on tumors that are accessible to the ExAblate 4000 device and aims to gather data for future research. The study does not include formal hypothesis testing but seeks to understand treatment safety and tumor management. Participants will receive focused ultrasound treatment using the ExAblate 4000 system targeting benign brain tumors. This study involves a single treatment arm where all participants receive the investigational device therapy. The treatment is designed for subjects with tumors meeting specific criteria, including minimal hemorrhage risk and accessibility to the device. During the study, participants will be closely monitored from the procedure day through a 12-month follow-up period. Researchers will assess safety by tracking treatment-emergent adverse events and measure tumor volume changes over time. Additional evaluations include neurological exams, physical exams, visual field testing, and both clinician and patient impressions of change. Participants andor their caregivers will maintain seizure diaries, and the study includes regular follow-ups to evaluate overall health and neurological status.

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.

Researchers are evaluating the antitumor activity and safety of JZP3507 in adults with recurrent Grade 2 or 3 meningiomas who have not responded to previous treatments. This Phase 2 study focuses on participants with measurable progressive disease who are unable or have declined standard care options. The goal is to assess how well JZP3507 works and its tolerability in this patient group. Participants will receive oral doses of JZP3507 twice daily on three consecutive days each week in 28-day cycles. This treatment will continue as long as the participant benefits or until disease progression or unacceptable side effects occur. The study involves a single group receiving JZP3507 without a comparison group or placebo. During the study, participants will undergo regular imaging tests and laboratory assessments to monitor disease status and treatment effects. Researchers will measure response rates using the Response Assessment in Neuro-Oncology criteria and track safety by recording adverse events and pharmacokinetic data over up to 36 months. Participants will be followed up for progression-free survival, overall survival, and treatment tolerability throughout the study period.