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Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma. The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making. The primary research questions are: - Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis? - Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and...
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Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. Compared with the gold- standard for brain imaging, magnetic resonance imaging (MRI), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. In addition, while MRI is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused...
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Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
This research is being done to investigate a treatment regimen of Irinotecan, Temozolomide, and Sargramostin, and an immunotherapy called Naxitamab and whether giving Naxitamab more slowly reduces the side effects for participants with relapsed or refractory neuroblastoma. The name of the study drugs involved in this study are: - Naxitamab (A type of monoclonal antibody) - Irinotecan (A standard of care chemotherapy) - Temozolomide (A standard of care chemotherapy) - Sargramostim (A standard of care, granulocyte-macrophage colony stimulating factor)
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Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.
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FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients
The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients.
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Fertility Preservation in Children With Solid Tumors: Detection of Residual Disease by a Sensitive Method
In prepubertal patients, cryopreservation of ovarian or testicular tissue is currently the only available method for fertility preservation prior to gonadotoxic cancer treatments. However, this approach carries the risk of reintroducing malignant cells upon autotransplantation, particularly in cases of metastatic cancers such as neuroblastoma and Ewing sarcoma. Therefore, it is crucial to employ highly sensitive techniques to detect minimal residual disease (MRD) in preserved gonadal tissues. This study aims to identify the most effective detection method by comparing the sensitivity and specificity of reverse transcription quantitative PCR (RT-qPCR) and droplet digital PCR...
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FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma
The goal of this clinical trial is to evaluate the performance characteristics of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of [18F]FET-PET in delineating disease. The main question[s] it aims to answer are: - whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression - whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT...
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FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.
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FG001 in Subjects with Meningiomas or Presumed Low-Grade Gliomas Scheduled for Neurosurgery
In neurosurgery both the diffusely infiltrated gliomas of the brain as well as the border towards healthy tissue in the meninges is a challenge. For the high-grade contrast enhanced gliomas fluorescent drugs like Gliolan have been used in several years and proved its clinical value. For non-contrast enhanced gliomas, like low-grade glioma, no such drug exist. The transition zone towards healthy non-tumor cell infiltrated brain in such low-grade gliomas is extremely difficult but for these patients their prognosis depends on the amount of non-healthy tissue left behind. Also, in benign tumors as meningioma the complete resection including infiltrated meninges is of importance for...
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Financial Toxicity and Patient-Reported Outcomes in GEP-NEN During Treatment
The aim of this study is to evaluate the financial toxicity reported by Italian patients affected by GEP-NEN during the first year of treatment after diagnosis and its correlations with patient-reported outcomes (PROs) and quality of life (QoL).
