Meningioma

Researchers are evaluating new treatment options for meningiomas that continue to grow despite prior local therapies like surgery and radiotherapy. This study focuses on a precision medicine approach combining diagnostic patient selection with PET molecular imaging and a targeted systemic radioligand therapy called [177Lu]Lu-DOTATATE. This is the first randomized trial investigating this therapy in patients with refractory meningioma, aiming to open new avenues for treatment and research in this area. Participants are randomly assigned to receive either the experimental therapy with intravenous [177Lu]Lu-DOTATATE at a dose of 7.4 GBq every four weeks for four cycles or a control group receiving local standard care as decided by their physician. The control treatments may include hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or no treatment with observation and supportive care. This randomized Phase II study compares the impact of these approaches on meningioma progression. During the study, participants will undergo regular assessments including MRI scans, PET imaging, neurological function evaluations using the NANO scale, and health-related quality of life questionnaires. Researchers will monitor disease progression, survival, radiological response, and treatment side effects up to two years after enrollment. Liver, kidney, blood, and electrolyte function are also checked before treatment. Participants will be followed closely to evaluate the treatment's effect and safety throughout the study period.

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.

Meningiomas are the most common primary intracranial tumors and are often surgically resectable. However, the intraoperative texture and adhesion of the tumor to surrounding structures vary widely and directly impact the surgical approach, difficulty, and outcomes. Current preoperative imaging lacks the ability to quantitatively assess biomechanical properties such as stiffness and adhesion, which are critical for neurosurgical planning. This prospective clinical trial investigates the application of 3D magnetic resonance elastography (MRE) in characterizing the biomechanical properties of meningiomas. Specifically, it aims to quantify tumor stiffness and adhesion using MRE-derived shear modulus maps and correlate these measurements with intraoperative surgeon-assessed stiffness/adhesion scores and postoperative histopathology. The study will also assess the diagnostic performance of MRE in predicting challenging resections, high tumor adhesion, and histological subtypes. Approximately 300 patients with radiologically confirmed meningioma scheduled for elective resection will be enrolled. Participants will undergo standard MRI and additional 3D MRE scanning. Intraoperative findings including tumor stiffness, adhesion, blood supply, and resection difficulty will be systematically recorded. Postoperative pathological analysis will include tumor grade and histological subtype. Statistical analyses will evaluate correlations, diagnostic accuracy, and potential prognostic value. Findings from this study may support the use of 3D MRE as a valuable noninvasive tool in preoperative assessment of meningiomas, helping optimize surgical strategies, reduce complications, and inform treatment decisions.

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.

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 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 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 PET/CT and SPECT/CT scans. About 30 patients with confirmed positive expression of SSTR2 and integrin 23 will undergo imaging to assess the tracer's 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 PET/CT and SPECT/CT 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 studying the safety and feasibility of using the ExAblate 4000 System, a focused ultrasound device, to treat benign centrally located brain tumors in children and young adults aged 5 to 22 years. The study aims to gather data to support future research on managing these tumors, which require clinical intervention and are accessible to the ExAblate device. Participants will receive treatment with the ExAblate 4000 System in a single-arm, non-randomized setting. This means all enrolled subjects will undergo the focused ultrasound procedure targeting their benign brain tumors. The study does not include a comparison group, and its main purpose is to assess safety and feasibility rather than test effectiveness. Throughout the study, participants will be monitored closely with assessments including tumor volume measurements and evaluations of physical and neurological health for up to 12 months after treatment. Researchers will also track side effects, visual field function, and both clinician and patient impressions of change. This detailed follow-up helps understand how the treatment affects the tumor and overall health over time.

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 mg/kg 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 mL/kg 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.