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Blood Brain Barrier Differences In Patients With Brain Tumors Undergoing Surgery
Rochester, MN
This pilot research trial studies blood brain barrier differences in patients with brain tumors undergoing surgery. Studying samples of tissue and blood from patients with brain tumors in the laboratory may help doctors to understand how well drugs get into different parts of a brain tumor. This may help them to determine which types of drugs may be best for treating brain tumors.
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CraniSeal Post Approval Study
Jacksonville, FL; Rochester, MN
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.
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Mayo Clinic Cancer Center Neuro-Oncology Program Registry And Biobank For The Study Of Nervous System Tumors
Rochester, MN
Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.
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Extracellular Impact Of Ultrasound-induced Blood-brain Barrier Disruption
Rochester, MN
The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.
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A Study To Evaluate The Surgical Removal Of Residual Brain Tumors Prior To Recurrence
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors. Eligible patients with surgically accessible latent tumors desiring surgical resection will be enrolled to prospectively track short- and long-term outcomes. Safety will be evaluated by quantifying rates of surgical morbidity as compared to patients undergoing RT after surgery, or no surgery for similar latent disease. Variables evaluated will include postoperative complications including death within 30 days, wound infection, length of hospital stay, and readmission rates.
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Human Blood and Tissues Repository for Neuroscience Research
Jacksonville, FL
The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).
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A Study to Evaluate The Use of Intravenous Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery for Vestibular Schwannomas (VS)
Rochester, MN
The purpose of this study is to evaluate the benefit of using intravenous fluorescein sodium (FS) and YELLOW 560 nm microscope filter (YE560) during surgery for vestibular schwannomas (VS), Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma and to determine the optimum FS dose and timing to be used with the YE560 device.
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Pituitary tumor registry
Rochester, MN
The purpose of this data registry involves the collection of standard of care clinical treatment regimens, diagnostic information and surgical outcomes which may include human specimens and associated genomewide expression data.
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Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection
Jacksonville, FL
We will be comparing circular grid to a strip electrode to record electrocorticography.
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A Study Of Using Magnetic Resonance Elastography To Measure Stiffness (Mechanical Properties) Of The Meningioma And Other Brain Tumors Similar To Meningiomas
Rochester, MN
The purpose of this study is to demonstrate improved planning for meningioma and similar brain tumor surgery.
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Comparing The Addition Of Radiation Either Before Or After Surgery For Patients With Brain Metastases
Jacksonville, FL
The purpose of this study is to compare the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases).
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Dinutuximab With Chemotherapy, Surgery And Stem Cell Transplantation For The Treatment Of Children With Newly Diagnosed High Risk Neuroblastoma
Rochester, MN
The purpose of this stduy tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing ...
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EF-41/KEYNOTE D58: Phase 3 Study Of Optune Concomitant With Temozolomide Plus Pembrolizumab In Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
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Ommaya Placement For Biomarker Collection
Rochester, MN
The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.
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Blood-Brain Barrier Disruption (BBBD) For Liquid Biopsy In Subjects With GlioBlastoma Brain Tumors
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of using Exablate Model 4000 Type-2.0/2.1 in adults with Glioblastoma brain tumors to increase temporarily the permeability of the blood brain barrier, allowing increased passage of circulating free DNA (cfDNA) for sampling and analysis.
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Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection
Rochester, MN
The objectives of this study are to determine the impact of omega-3 supplementation on promoting facial nerve function recovery, and to determine the impact of omega-3 supplementation on Vestibular schwannoma (VS) tumor control.
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A Study To Evaluate Advanced Development Of Desorption Electrospray Ionization Mass Spectrometry For Intraoperative Molecular Diagnosis Of Brain Cancer
Jacksonville, FL
The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.
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A Study for Cerebral Open Flow Microperfusion
Rochester, MN
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research’s cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
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Feasibility Of Intraoperative Microdialysis During Neurosurgery For Central Nervous System Malignancies
Rochester, MN
This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.
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Effects of Cognitive Function, Post-op Fatigue and Quality of Life Comparing General vs Regional Anesthesia for Non-eloquent Brain Tumors Resection
Jacksonville, FL
The aim of the study is to create a registry to prospectively collect pre-operative, during surgery and post-operative data, questionaries will assess (at baseline before the surgery, 3-4 weeks, and at 3-6 months) cognitive function, assessed with a Mini-mental State Examination (MMSE), PROMIS Fatigue 7a form, quality of life (QoL), assessed using the SF-12 questionnaire, quality of sleep assessed using PROMIS Sleep disturbance 7a form (1 week after surgery).
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Intratumoral Extracellular Metabolic Impact Of DFMO And AMXT 1501 In Patients With Diffuse Or High Grade Glioma
Rochester, MN
The purpose of this study is to determine how polyamine depletion impacts extracellular intratumoral guanidinoacetate abundance.
In addition: to determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ; to assess the feasibility of longitudinal microdialysis for combined pharmacokinetic and pharmacodynamic analysis within live human gliomas in situ in the postoperative setting; to assess the CNS pharmacokinetics of DFMO and AMXT 1501; to assess the short-term safety of study drugs in patients with high-grade gliomas.
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A Study to Test Concussion Return to Baseline after Elective Craniotomy Procedure
Jacksonville, FL
The purpose of this study is to determine return to baseline (RTB) period after an elective craniotomy procedure using the ImPACT testing assessment.
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A Study of Fluorine F 18 Fluorodopa-Labeled PET Scans for Planning Surgery and Radiation Therapy to Treat Patients who have Newly Diagnosed High- or Low-Grade Glioma Brain Cancer Tumors
Rochester, MN
The purpose of this study is to evaluate the use of fluorine F 18 fluorodopa-labeled PET scanning for the planning of surgery and radiation therapy to treat patients who have newly diagnosed high- or low-grade glioma brain tumors. New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scans, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.
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Image-based Mapping Of Brain Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.
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A Study To Determine How BI 907828 Is Taken Up In The Tumor And To Determine The Highest Dose Of BI 907828 That Could Be Tolerated In Combination With Radiation Therapy In People With A Brain Tumor Called Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.
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A Trial To Evaluate Multiple Regimens In Newly Diagnosed And Recurrent Glioblastoma
Jacksonville, FL; Rochester, MN
The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
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Ommaya At Biopsy
Rochester, MN
The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.
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A Study to Use a Patient Monitoring Application that Monitors Physiological Data, Psychosocial Data, and Responses to Survey Questions in Patients Undergoing Cranial or Spinal Surgery
Rochester, MN
The purpose of this study is to use a patient monitoring application that monitors physiological data, psychosocial data, and responses to survey questions collected during a one month pre and three and six month postoperative observation period.
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Pre-operative Vs. Post-operative Radiosurgery For Metastatic Brain Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine whether there is an increase in the time of a first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients with brain metastases who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
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The NeoGlioma Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.
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Dose-Escalated Photon IMRT Or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy And Temozolomide In Treating Patients With Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Rochester, MN
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...
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Reducing Smoke Exposure in Children Facing Surgery
Rochester, MN
The purpose of this study is to see whether advice by clinicians to cigarette smokers who are parents of children undergoing elective surgery can reduce the exposure of these children to secondhand smoke in the time around surgery.
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Cerebrospinal Fluid Biomarkers For Brain Tumors
Rochester, MN
The purpose of this study is to help generate a repository of Cerebrospinal Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.
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A Study To Explore If It Is Possible To Successfully Obtain Optical Coherence Tomography (OCT) Imaging And Data While Patients Undergo Brain Surgery
Jacksonville, FL
The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.