[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radionecrosis-of-brain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radionecrosis-of-brain":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100552313","phase-3-corticodependent-or-corticoresistant-brain-radionecrosis-after-radiotherapy-for-brain-metastases-100552313",false,"NCT06471465","Corticodependent or Corticoresistant Brain Radionecrosis After Radiotherapy for Brain Metastases","Corticodependent or Corticoresistant Brain Radionecrosis After Radiotherapy for Brain Metastases: a Multicentre Randomized, Controlled Double-blind Phase III Study, Comparing Bevacizumab Versus Placebo","BRADI","Inclusion Criteria:\n\n* Patient with a diagnosis of radionecrosis based on a clinical onset of symptoms and radiological findings of RN following radiotherapy, with or without pathological confirmation:\n\nMRI evidence to support the diagnosis of RN (transient increase in irradiated lesion volume -FLAIR hypersignal and\u002For enhanced portion- without rCBV increase) COMBINED with nuclear medicine imaging:\n\nbiphasic 18FDG-PET-TDM\u002FMRI according to Horky or 18F-FDOPA with stage 0-1 according to Lizarraga;\n\n* Symptoms are persistent or worsening despite administration of corticosteroids: at least 1 mg\u002Fkg\u002Fd of prednisolone or equivalent:\n\nCorticoresistant: neurological symptoms despite administration of at least 2 weeks of 1 mg\u002Fkg\u002Fd prednisolone or equivalent; Corticodependant: worsening of neurological signs or symptoms after an initial improvement when weaning off steroids at a dose \\\u003C 0.5 mg\u002Fkg\u002Fd prednisolone or equivalent;\n\n* Patients must have received the last cranial irradiation with photons or proton therapy for brain metastases ≥ 3 months with one or more sequences;\n* Age≥18-year-old;\n* ECOG performance status score ≤ 3\n* Life expectancy of at least 3 months assessed by graded prognostic score (DS-GPA) score 0.5 or greater;\n* Patient who has never received Bevacizumab for the indication of radionecrosis.\n* Adequate organ function:\n\nBone marrow function\n\n* Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 Platelet Count ≥ 100,000\u002Fmm3, Haemoglobin ≥ 10 g\u002FdL (allowing transfusion or other intervention to achieve this minimum haemoglobin) Coagulation\n* International normalized ratio (INR) or prothrombin time \\\u003C 1.5 × ULN Renal function\n* No proteinuria with urine dipstick for proteinuria \\> 2+\n* Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL\u002Fmin (measured or calculated using the CDK-EPI formula) Hepatic Function\n* Total bilirubin ≤1.5 x the upper limit of normal (ULN)\n* Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN\n\n  * Women of childbearing potential must use effective contraceptive measures during the treatment and for 6 months following its cessation;\n  * Signed informed consent;\n  * Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Evidence of active bleeding or a pathological condition at high risk of bleeding: CNS hemorrhage, bleeding diathesis or coagulopathy, hemoptysis (\\>2.5ml of bright red blood per episode), evidence of history of bowel obstruction, abdominal fistula, or gastrointestinal tract perforation or gastro intestinal abscess occurring less than 28 days prior study entry;\n* Grade 4 venous thromboelism and peripheral arterial thrombus\n* Evidence of very high intracranial pressure that suggests brain hernia and needs emergency surgery;\n* Major surgical procedure or significant traumatic injury less than 28 days prior study entry; minor surgery within 3 days prior to initiation of study treatment;\n* Clinically significant cardiovascular disease such as uncontrolled arterial hypertension (BP ≥160 mm Hg or diastolic BP ≥100 mm Hg despite maximal medical therapy), cerebrovascular event, myocardial infarction, cardiac arrhythmias, unstable angina, or congestive heart failure within the last 6 months;\n* History of hypertensive crisis or hypertensive encephalopathy\n* Patients scheduled to undergo head and neck, thoracic, or abdominal radiotherapy during the study treatment\n* Prior bevacizumab ≤ 3 months before randomization;\n* Progressive brain metastases;\n* History of severe allergic anaphylactic reactions to bevacizumab\n* Patients with a known hypersensitivity to the active substance or to any of the excipients of bevacizumab are not eligible for participation;\n* Patients with a contraindication to the treatment with bevacizumab according to the European SmPC\n* Patient pregnant and\u002For nursing;\n* Mental impairment (psychiatric illness\u002Fsocial situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;\n* Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship;\n* New cerebral metastasis detected during the inclusion imaging evaluation;\n* Prior diagnosis of Posterior Reversible Encephalopathy Syndrome (PRES) with bevacizumab;\n* Hypersensitivity known to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.","ALL","18 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Brain metastases (BM) afflict a significant portion of cancer patients, ranging from 10% to 50%, leading to debilitating symptoms and diminished quality of life, thereby impacting overall survival. Treatment options typically include surgery, stereotactic radiosurgery (SRS), and whole brain radiotherapy (WBRT). SRS has emerged as the preferred focal treatment due to its efficacy, delivering ablative doses with notable overall survival benefits, especially for single BM or postoperative cases, while being less invasive than neurosurgery and capable of addressing inoperable sites and multiple lesions. Contrastingly, WBRT is now reserved for select cases with multiple BMs ineligible for SRS, owing to its lower rate of neurocognitive toxicities and high local control rates at one year.\n\nDespite its advantages, SRS can engender late side effects, with cerebral radio necrosis (RN) being the most common, occurring in approximately 10% of patients treated. The exact pathophysiology of RN remains unclear but is thought to involve vascular injury, immune-mediated mechanisms, and direct neuronal effects, culminating in radiological changes or symptomatic manifestations necessitating treatment. Corticosteroids are the mainstay therapy, albeit with associated side effects and instances of cortico-resistance or cortico-dependence. Bevacizumab, an anti-VEGF agent, has shown promise in small studies but awaits validation in larger trials.\n\nConsequently, a randomized phase III trial seeks to evaluate the efficacy of adding bevacizumab to standard corticosteroid therapy in patients with symptomatic RN. The trial aims to determine if this combination therapy yields superior symptomatic improvement compared to corticosteroids alone. RN will be diagnosed using multimodal imaging, and the primary objective is to assess the efficacy of bevacizumab in reducing corticosteroid usage and neurological symptoms associated with RN at three months. Secondary endpoints include toxicities, quality of life, imaging changes, and response duration. Additionally, an ancillary study will explore correlations between initial imaging parameters and treatment response, as well as changes in biological parameters with bevacizumab therapy.",[27,28],"Radionecrosis of Brain","Brain Metastases",[30,31,32,33],"radionecrosis of brain","brain metastasis","quality of life","bevacizumab","RECRUITING","2025-08-13",{"date":37,"type":38},"2025-08-17","ACTUAL",{"date":40,"type":38},"2025-04-29",{"date":42,"type":21},"2030-08",{"name":44,"class":45},"Institut Cancerologie de l'Ouest","OTHER",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100517354","phase-2-a-study-of-chlorophyllin-for-the-management-of-brain-radio-necrosis-in-patients-with-diffuse-glioma-100517354","NCT06016452","A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma","A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma","CHROME","Inclusion Criteria:\n\n* Histological diagnosis of diffuse glioma.\n* Radionecrosis on imaging with new neurological symptoms\u002F worsening of prior deficits (Stratum A) or\n* without new symptoms (Stratum B).\n* Karnofsky Performance Scale (KPS) ≥ 50.\n\nExclusion Criteria:\n\n* No tissue diagnosis.\n* KPS\\\u003C 50.\n* Disease progression\n* Contraindications to corticosteroids.\n* Altered mental status with deficits in understanding or inability to consent to the study.\n* Brainstem glioma\n* Indeterminate for radionecrosis vs disease progression\n* Prior treatment with bevacizumab (either for disease progression or radionecrosis)","70 Years",{"count":57,"type":21},118,[59],"PHASE2","Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN).\n\nAt the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients.\n\nThis is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis.\n\nChlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent.\n\nThis is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years.\n\nThe study is funded by Bhabha Atomic Research Centre (BARC).",[62,27,63,64],"Diffuse Glioma","High Grade Glioma","Glioblastoma Multiforme","2025-04-08",{"date":67,"type":38},"2025-04-11",{"date":69,"type":38},"2023-11-13",{"date":71,"type":21},"2025-11",{"name":73,"class":45},"Tata Memorial Centre",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100553025","fet-pet-guided-management-of-pseudoprogression-in-glioblastoma-100553025","NCT06480721","FET-PET-Guided Management of Pseudoprogression in Glioblastoma","FET-POPPING","Inclusion Criteria:\n\n* Patients with a glioblastoma, IDH-wildtype, World Health Organization (WHO) grade 4, according to WHO 2021 criteria.\n* Age ≥18 years\n* New or increased enhancement within the high-dose radiation field (defined as within the 80% isodose line) on follow-up MRI\n* Follow up MRI ≥3 months after the end of the standard-of-care temozolomide-based concomitant chemoradiation (60 Gy\u002F30 fractions or 40 Gy\u002F15 fractions). Of note, very early increase - within 3 months of last radiation - will not be grounds for inclusion because of the high rate of pseudoprogression and slightly lower diagnostic performance of FET-PET compared to the situation of increase beyond 3 months after last radiation. Patients with such very early increase may have subsequent further increase after 3 months post-radiation, causing (further) diagnostic doubt; these may be included at that later timepoint if they meet the other inclusion criteria.\n* First moment of clinicoradiological uncertainty regarding the diagnosis (≥3 months after the end of chemoradiation): pseudoprogression or tumor recurrence. The determination of 'uncertainty' is made by the treating physician, preferably in the multidisciplinary tumor board, based on available clinical and standard-of-care MRI-data, which generally includes perfusion-MRI.\n* Previous usage of bevacizumab as a symptom treatment is allowed. However, inclusion is only allowed at the first moment of clinical doubt between pseudoprogression and tumor recurrence, not at later timepoints.\n\nExclusion Criteria:\n\n* Previous treatment for recurrence of disease\n* An enhanced lesion size of less than 1 cm on the index MRI. In the newest RANO PET criteria, it is advised to use FET-PET for increasing lesions only in cases with a minimum lesion size.\n* Life expectancy of less than 6 months, determined by the treating physician\n* Contra-indications for PET (claustrophobia, inability to lay still)\n* Women of childbearing potential without adequate contraception\n* Any other concomitant disease that may influence PET imaging or clinical outcomes of this study, this includes but is not limited to: cerebral inflammatory diseases and other cancers with brain- or leptomeningeal metastases",{"count":83,"type":21},144,[85],"NA","The goal of this diagnostic randomised clinical trial is to determine, in glioblastoma patients with diagnostic uncertainty between pseudoprogression and tumor progression on follow-up MRI after chemoradiation, the added value of a direct \\[¹⁸F\\] FET-PET scan for clinical management.\n\nThe main questions it aims to answer are:\n\n* Does the clinical management guided by an additional FET-PET scan leads to fewer unnecessary interventions, compared with management based on MRI only?\n* Does the clinical management guided by an additional FET-PET scan leads to better health-related quality of life after 12 weeks, compared with management based on MRI only?\n* Does the clinical management guided by an additional FET-PET scan leads to reduced net healthcare costs, compared with management based on MRI only?\n\nResearchers will compare the investigational arm, where clinical management is based on the index MRI scan and an additional FET-PET scan, with the control arm, where clinical management is based solely on the index MRI scan, to investigate the added value of the FET PET scan for clinical management.\n\nParticipants in the investigational arm will undergo the FET PET scan. All participants will complete health-related quality of life questionnaires at four different timepoints.",[88,27],"Glioblastoma",[88,90,91,92,93,94,95],"[¹⁸F] FET PET","Tumor progression","Pseudoprogression","Unnecessary interventions","Health-related quality of life","Healthcare costs","NOT_YET_RECRUITING","2024-06-24",{"date":99,"type":38},"2024-06-28",{"date":101,"type":21},"2024-08",{"date":103,"type":21},"2027-12",{"name":105,"class":45},"Veerle Ruijters",8]