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Belzutifan With Von Hippel-Lindau (VHL)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to characterize the effectiveness of belzutifan for patients with VHL disease-associated RCC and/or CNS hemangioblastoma treated in real-world clinical practice. The primary effectiveness parameter includes tumor reductive procedures given the clinical importance of this parameter and association with subsequent morbidity and mortality of disease.
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A Study Of The Drugs Selumetinib Vs. Carboplatin And Vincristine In Patients With Low-Grade Glioma
Rochester, MN
This study aims to demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).
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Proton Beam Or Intensity-Modulated Radiation Therapy In Preserving Brain Function In Patients With IDH Mutant Grade II Or III Glioma
Rochester, MN
This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if ...
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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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Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
Rochester, MN
The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.
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A Study Of Lutetium Lu 177 Dotatate (Lutathera®) In Patients With Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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A Study To Compare Treatment With The Drug Selumetinib Alone Versus Selumetinib And Vinblastine In Patients With Recurrent Or Progressive Low-Grade Glioma
Rochester, MN
The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.
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A Study Of Nivolumab And Multi-fraction Stereotactic Radiosurgery With Or Without Ipilimumab In Treating Participants With Recurrent Grade II-III Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating participants with grade II-III meningioma that has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab and multi-fraction ...
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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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Quality of Life in Patients with Acoustic Neuromas
Rochester, MN
Acoustic neuromas (also known as vestibular schwannomas) are benign slow growing tumors that arise from the vestibular portion of the eighth cranial nerve. Current treatment options include microsurgery, stereotactic radiosurgery and observation, using a “wait-and-scan” approach. The primary objective of this study is to compare long-term quality of life outcomes between treatments for sporadic acoustic neuromas.
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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.
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Effect of Agent Orange Exposure on Endocrine Tumor Aggressiveness
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The intent is to collect relevant clinical data on patients exposed to Agent Orange plus assessment of the tissue for genetic mutations known to be associated with growth of thyroid cancer and pituitary tumors and report our findings as a descriptive case series.
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Mayo Clinic Vestibular Schwannoma Quality of Life Index Assessment
Rochester, MN
The purpose of the study is to conduct cognitive testing of the recently published Mayo Clinic Vestibular Schwannoma Quality of Life (VSQOL) Index.
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Primary Tumor Research And Outcome Network (PTRON) Registry
Rochester, MN
The purpose of this registry is to collect clinical, diagnostic, and therapeutic data specific for primary spinal column tumor patients, and evaluate it to understand the predictive factors which influence survival, local recurrence, adverse events, perioperative morbidity, and health related quality of life.
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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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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 Of Zanzalintinib In Participants With Recurrent Or Progressive Meningioma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.
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A Study Of ATR-101 For The Treatment Of Cushing’s Syndrome
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of ATR-101 for the treatment of adults who have internally caused Cushings syndrome.
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A Study to Evaluate Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
Rochester, MN
The purpose of this study is to investigate if a blood test measuring copeptin within 24 hours following pituitary surgery could predict development of diabetes insipidus (increased urination and thirst with fluid balance problems) as opposed to the clinical methods we currently use.
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[18F] Fluoroethyl-L-tyrosine PET/MRI for identifying small functional pituitary adenomas
Jacksonville, FL
The purpose of this research is to evaluate the diagnostic role and clinical efficacy of [18F]FET-PET/MRI in detecting MRI-occult primary or residual/recurrent functional pituitary adenomas (PAs) and its influence on clinical and surgical decisions.
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Anti-VEGF Gene Therapy Trial For Vestibular Schwannoma
Rochester, MN
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
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A Study to Develop and Validate a New Disease-Specific Quality of Life Index for Sporadic Vestibular Schwannoma
Rochester, MN
The purpose of this study is to develop and validate a new disease-specific, quality-of-life (QOL) index for sporadic Vestibular Schwannoma (VS) that addresses key shortcomings of previous instruments.
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FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Rochester, MN
The purpose of this study is to evaluate the performance [sensitivity, specificity, accuracy] of 18Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET/CT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.
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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 To Evaluate Endoscopic Endonasal Skull Base Surgery And Pituitary Surgery Quality Of Life
Rochester, MN
The objectives of this study are to:
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- Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
- Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
- Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
- Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
- Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.
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Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing’s Disease
Rochester, MN
The purpose of this study is to combine recent advances in ultrasound imaging, specifically an endonasal transducer array and contrast enhanced ultrasound, to offer an intraoperative image-guided solution for lesion-specific surgical resection to impact clinical outcome.
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Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2
Rochester, MN
The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.
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Patient Adherence and Symptoms During Post-operative Fluid Restriction Protocol After Transsphenoidal Surgery
Jacksonville, FL
The objectives of this study are to survey patients during the post-operative period regarding their experience with fluid restriction including adherence and discomfort, and to document rates of hyponatremia and readmissions in post-operative patients.
Advances in endonasal, endoscopic transsphenoidal surgical techniques have decreased complications and length of stay for persons undergoing resection of sellar and suprasellar masses Previous research by investigators now at Mayo (SLS, AQH) has shown that particular interventions including fluid restriction post-operatively decrease patient morbidity (e.g., from hyponatremia) and readmissions while maintaining patient safety. However, the patient perspective on the impact of fluid restriction has not ...