[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioma-astrocytic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioma-astrocytic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100480162","evaluation-of-ex-vivo-drug-combination-optimization-platform-in-recurrent-high-grade-astrocytic-glioma-100480162",false,"NCT05532397","Evaluation of ex Vivo Drug Combination Optimization Platform in Recurrent High Grade Astrocytic Glioma","Inclusion Criteria:\n\nPre-screening:\n\n1. Patients 21 years of age or older, with ECOG performance status 0 to 2, and with a life expectancy of more than 3 months with suspected high grade astrocytic glioma, fit for treatment comprising standard-of-care therapy with adjuvant temozolomide and radiotherapy if the diagnosis of high grade astrocytoma is pathologically confirmed.\n2. Signed informed consent obtained before any study specific procedure. Subjects must be able to understand and be willing to sign the written informed consent.\n\n   * Patients will be enrolled at the time of initial surgery but study imaging and further PDO generation will not take place if the patient is subsequently found not to meet the histological criteria or will not be receiving standard adjuvant temozolomide\u002F radiotherapy.\n\nAll subsequent criteria apply to the main study only:\n\n1. Patients 21 years of age or older, with ECOG performance status 0 to 2, and life expectancy of more than 3 months with pathologically confirmed high grade astrocytic glioma, having undergone first-line standard-of-care therapy with surgery\u002Fbiopsy followed by temozolomide and radiotherapy. Subjects with truncated adjuvant chemoradiotherapy may be enrolled at the Principal Investigator's discretion.\n2. Documented tumor progression based on standard clinical, radiological or histological criteria, and deemed suitable for second line systemic therapy.\n3. Sufficient tumor tissue available for PDO generation at baseline and at least one available or pending QPOP result.\n4. Adequate organ function as defined by:\n\n1\\. Bone marrow function i. Haemoglobin ≥ 9g\u002Fdl ii. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL iii. Platelet count ≥ 100 x 109\u002FL. 2. Liver function i. Bilirubin \\\u003C 2.5x upper limit of normal (ULN) ii. Alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C 2.5x ULN or \\\u003C 5x ULN if liver metastases are present iii. Prothrombin time (PT) within the normal range for the institution. 3. Renal function i. Plasma creatinine \\\u003C1.5x institutional ULN 5) Capable of swallowing tablets. 6) Recovery from any previous drug- or procedure-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 0 or 1 (except alopecia), or to baseline preceding the prior treatment.\n\nExclusion Criteria (both pre-screening\u002F main study)\n\n1. Chemotherapy, radiotherapy, surgery, immunotherapy or other therapy within 2 weeks of study entry.\n2. Pregnancy or breastfeeding at the point where systemic anti-cancer therapy is initiated. Women of childbearing potential must have a negative pregnancy test at the point where systemic anti-cancer therapy is initiated. Women of childbearing potential and men, must agree to use adequate contraception (barrier method of birth control) while on anti-cancer treatment and until at least 3 months after the last study drug administration.\n3. Concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis \\& T1) or any cancer curatively treated less than 5 years prior to study entry.\n4. Patients with leptomeningeal dissemination of disease and\u002For pure spinal high grade gliomas will be excluded.\n5. Kidney disease which would clinically disqualify the subject from serial MRI scans with gadolinium contrast.","ALL","21 Years","99 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is an interventional, non-randomized, single site study. Brain tumor samples will be collected from patients for organoids generation and subject to panel drugs screening and QPOP analysis to derive the optimal drug combinations for treatment at the time of first high grade astrocytic glioma recurrence. The investigators hypothesize that patient-derived organoids (PDOs) mimic the biological characteristics of high grade astrocytic gliomas and serve as an ideal platform for the evaluation of drug sensitivities, accurately reflecting the patient's therapeutic response to the drugs.",[26],"Glioma, Astrocytic",[28,29,30],"QPOP","patient-derived organoids (PDOs)","TMZ\u002FRT resistance","RECRUITING","2025-09-21",{"date":34,"type":35},"2025-09-23","ACTUAL",{"date":37,"type":35},"2023-02-17",{"date":39,"type":20},"2026-12",{"name":41,"class":42},"National University Hospital, Singapore","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100560079","uspio-enhanced-mr-imaging-in-cns-tumours-umic-100560079","NCT06572475","USPIO Enhanced MR Imaging in CNS Tumours (UMIC)","USPIO Enhanced MR Imaging in CNS Tumours (UMIC) : A Pilot Study of Ferumoxytol (Feraheme ©) as an Imaging Biomarker of Tumour Associated Macrophage (TAM) Infiltration in Vestibular Schwannoma (VS) and Transforming Low Grade Glioma (LGG)","UMIC","Inclusion Criteria:\n\n* Be at least 16 years old\n* Have a CNS tumour suspected to be one of the defined histological types (vestibular scwhannoma or low grade glioma)\n* Be able to lie still for up to 1 hour comfortably\n* Opinion of the treating clinician is that the patient will be able to successfully complete the research imaging protocol.\n\nExclusion Criteria:\n\n* Life expectancy less than 1 year\n* Previous CNS radiotherapy\u002F stereotactic radiosurgery (SRS)\n* Females who are pregnant\u002F breastfeeding\n* Patients with an eGFR \\\u003C 30ml\u002Fmin\n* Patients with known and documented history of iron overload\u002Fhaemosiderosis\u002F haemochromatosis\n* Patients with immune or inflammatory conditions e.g. systemic lupus erythematous, rheumatoid arthritis\n* Patients with absolute (e.g. pacemaker) and relative (anxiety or claustrophobia) contraindications to MR scanning\n* Patients with a history of allergic reaction to iron or dextran\n* Patients with a history of allergic reaction to gadolinium contrast agents, asthma or renal problems\n* Patients who are unable to adequately understand verbal explanations or written information given in English.","16 Years","100 Years",{"count":54,"type":20},17,[23],"The immune response or inflammation is known to be a key driver of progression and growth in many solid tumours. Inflammatory cells called macrophages are present in high numbers in many brain tumours and these tumour associated macrophages or TAM are thought to have prognosis and treatment implications in these tumours. A key question, however, is how this inflammation or TAM abundance can be detected, measured and monitored in the clinic. A clinically applicable imaging test that can directly and accurately measure tumour macrophage content would be of considerable value and one technique that may provide this is USPIO enhanced magnetic resonance imaging (MRI). Following intravenous injection, USPIO or ultrasmall superparamagnetic iron oxide nanoparticles, circulate in the bloodstream before being taken up by inflammatory cells\u002Fmacrophages in tumour tissue, wherein they can be detected by MRI. This pilot study is to evaluate if a commercially available USPIO preparation called ferumoxytol (Feraheme ©) can accurately quantify macrophage abundance in brain tumours, with an exploratory focus on vestibular schwannoma (VS) and suspected transforming low-grade glioma (LGG). Patients with both non-growing (static) and growing VS, and patients with suspected transforming LGG will undergo dedicated MRI sequences before, immediately after (\\\u003C 2 hours) and at both 24 and 48hrs after ferumoxytol administration. In patients undergoing surgery, acquired imaging will be compared with resected tumour tissue so that markers of inflammation can be compared with USPIO uptake. Through advanced laboratory methods this study will seek to establish within resected VS and LGG specimens: the cellular destination\u002Fs of USPIO uptake; the nature of the inflammatory and\u002For tumour cells containing the USPIO; and the relationship between USPIO uptake and tumour blood vessel permeability or leakiness.",[58,26],"Vestibular Schwannoma","2024-08-22",{"date":61,"type":35},"2024-08-27",{"date":63,"type":35},"2024-04-26",{"date":65,"type":20},"2026-12-31",{"name":67,"class":42},"Northern Care Alliance NHS Foundation Trust",1]