[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"grade-iii-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:grade-iii-glioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644902","safety-and-effectiveness-evaluation-of-temozolomide-amitzo-nanoalvand-in-patients-with-grade-iii-and-iv-glioma-tumors-100644902",false,"NCT07675070","Safety and Effectiveness Evaluation of Temozolomide (Amitzo, NanoAlvand) in Patients With Grade III and IV Glioma Tumors","A Phase IV and Observational Study to Evaluate Safety and Effectiveness of Temozolomide (Amitzo, NanoAlvand) Therapy in in Patients With Grade III and IV Glioma Tumors","Inclusion Criteria:\n\n* Patients with newly diagnosed grade III or IV glial tumors, or patients who have experienced disease recurrence or progression after receiving standard treatment and, based on the treating physician's diagnosis, require treatment with temozolomide\n* Patients aged 18-80 years old\n\nExclusion Criteria:\n\n* Patients without a baseline MRI\n* Patients who are unwilling to participate in the study","ALL","18 Years","80 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","This is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Amitzo® in Iranian patients with grade III and IV glioma tumors. No control group is considered in the study design. The primary objective is to evaluate the incidence of hepatic injury in patients with grade III and IV glioma tumors, treated with Amitzo®.",[25,26,27],"Brain Tumor","Grade III Glioma","Grade IV Glioma",[29,30,31,32,33,34,35],"Brain Neoplasms","Temozolomide","Effectiveness","Safety","Glioma","Amitzo","Adverse Event","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2026-03-22",{"date":44,"type":21},"2026-11",{"name":46,"class":47},"NanoAlvand","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100372929","early-phase-1-implantable-microdevice-in-primary-brain-tumors-100372929","NCT04135807","Implantable Microdevice In Primary Brain Tumors","A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors","Inclusion Criteria:\n\n* Patients must have operable supratentorial tumor presumed to be WHO grade II-IV glioma (Astrocytoma, Oligodendroglioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, or Glioblastoma) based on radiological evidence at MRI, where a gross total or partial surgical resection is intended.\n* Histological confirmation of WHO grade II-IV glioma at time of intraoperative frozen analysis (for newly diagnosed tumors). This is not necessary in cases where a histopathologic diagnosis is already available from prior surgeries\u002Fbiopsies.\n* Participants must be 18 years of age or older.\n* Karnofsky Performance Score ≥ 60 (Appendix C).\n* Participants must have normal organ and marrow function as defined below:\n\n  * Leukocytes ≥ 3,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional upper limit of normal\n  * Creatinine within normal institutional limits OR\n  * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n* Participants must be evaluated by a neurosurgeon who will determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor.\n* Because participants will be exposed to microdoses of therapeutic agents only in a localized setting and for a short period of time (2-4 hours), the risk of interaction with other drugs routinely assumed by participants is considered not applicable. Thus, participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes remain eligible.\n* The effects of the microdevice on the developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to have a negative serum pregnancy test within 48 hours prior to registration. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the microdevice or any agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because agents released by the microdevice have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding should be discontinued if the mother is treated in the study for a total of 14 days after removal of the microdevice.\n* Tumor size \\\u003C 5 cm3.\n* Tumor located in deep brain structures (e.g. thalamus, brainstem).\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures.\n* If there are significant risk factors (e.g. high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines, patients will be excluded from the trial.",{"count":57,"type":21},12,"INTERVENTIONAL",[60],"EARLY_PHASE1","This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors.\n\n* The device involved in this study is called a microdevice.\n* The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.",[63,26,27,64,65,66,67,68],"Grade II Glioma","Astrocytoma","Oligodendroglioma of Brain","Anaplastic Astrocytoma of Brain","Anaplastic Oligodendroglioma","Glioblastoma",[63,26,27,64,65,66,68],"2025-07-18",{"date":72,"type":40},"2025-07-23",{"date":74,"type":40},"2020-03-03",{"date":76,"type":21},"2028-06-01",{"name":78,"class":79},"Oliver Jonas","OTHER",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":87,"targetDuration":4,"studyType":58,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100591046","local-targeted-therapy-with-alpha-emitter-225acac-dota-sp-tat-in-glioma-who-g3-g4-progression-100591046","NCT06975332","Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression","Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy in Glioma (WHO G3-G4) Progression","Inclusion Criteria:\n\n* age 18-80;\n* histologically confirmed diffuse glioma (CNS WHO G3-G4);\n* after standard treatment with biopsy or resection, radiotherapy and\u002For chemotherapy;\n* tumour progression as defined by RANO 2.0 on MRI (hyperintense lesion on MRI or increase of maximal transverse diameter of tumour or increase on volumetric measurement, local progression by continuity in proximity of 4 cm to primary lesion after resection, stable lesion progression on MRI \\>25% in time between two consecutive MRIs or any new lesion on MRI; to differentiate progression from pseudoprogression a biopsy may be needed, especially within 12 weeks from radiotherapy);\n* unifocal lesion;\n* after resection: tumour volume \\\u003C50 ml AND tumour tissue thickness on contrast-enhanced T1 MRI \\\u003C1 cm;\n* after biopsy: tumour median diameter \\\u003C2 cm;\n* functional state \\>70 according to Karnofsky's performance scale (KPS);\n* ability to give informed consent to participate in the study.\n\nExclusion criteria:\n\n* necessity of urgent surgery (e.g., sudden increase in intracranial pressure);\n* significant postoperative complications: e.g., Karnofsky's performance scale (KPS) \\\u003C70, wound infection, cerebrospinal fluid leak;\n* ventricular shunt leak \\>10% during a control patency test;\n* open\u002Fcommunicating resection cavity;\n* mass effect on CT scan or MRI with midline shift of more than 5 mm and\u002For nausea, vomiting, altered consciousness, or clinically significant papilledema;\n* catheter obstruction;\n* predicted life expectancy less than 3 months;\n* patients without preserved logical-verbal contact or uncooperative;\n* inability to provide informed, voluntary consent to participate in the study;\n* patients participating in another medical experiment;\n* patients who have taken any other investigational drug within 1 month of the first dose;\n* prior treatment with \\[225Ac\\]Ac-DOTA-SP;\n* breastfeeding or pregnancy;\n* severe diseases of other organs that, in the opinion of the Investigator, significantly increase the risk of the procedure.",{"count":88,"type":21},35,[90],"NA","Brain tumors account for 1.35% of all cancers and cause 2.2% of cancer-related deaths. Gliomas are the most common type, comprising 40-90% of central nervous system tumors in different age groups. The incidence of malignant gliomas is approximately 0.5-2 per 100,000 people annually. Standard treatments include surgical resection, radiotherapy, and chemotherapy, yet overall survival remains low, typically 1-3 years post-diagnosis. The study highlights the pressing need for novel treatment strategies, particularly given the infiltrative nature of gliomas and the potential for targeted therapies using neuropeptides.\n\nThe aim of this study is to assess the efficacy and safety of local targeted therapy with \\[225Ac\\]Ac-DOTA-SP in recurrent glioblastoma.\n\nIt is an interventional study without a control group, initiated by the researcher. Patients included are aged 18-80 with recurrent WHO G3-G4 glioma post-first-line treatment, not requiring immediate surgery and meeting specific MRI progression criteria.\n\nPatients will receive a maximum of six cycles of \\[225Ac\\]Ac-DOTA-SP, involving pre-treatment assessments, local administration of the agent after ensuring catheter patency, and continuous monitoring. Blood tests and neurological evaluations will be performed regularly.\n\nOutcome will be assessed by measuring overall survival (OS) and progression-free survival (PFS). The study anticipates improvements in both OS and PFS when compared to current treatments, contributing to critical insights into targeted alpha therapy's effectiveness in glioblastoma.\n\nTreatment with \\[225Ac\\]Ac-DOTA-SP previously indicated few significant side effects, primarily transient issues like seizures. Patients will be closely monitored throughout the study to identify any adverse effects promptly.\n\nThe estimated study duration is three years, with biological material collected for histopathological and genetic analysis during surgical reoperation.\n\nData will be anonymized to protect patient confidentiality, stored securely, and made available only for the scope of the study.\n\nLed by Prof. Przemysław Kunert, the research team includes multiple co-investigators from neurosurgery and nuclear medicine departments.",[68,93,94,26],"High-Grade Gliomas","Grade III Astrocytoma",[96,97,98,99,100],"alpha emitter","glioblastoma recurrence","local therapy","225-Ac","high-grade glioma recurrence","2025-05-07",{"date":103,"type":40},"2025-05-16",{"date":105,"type":40},"2024-10-09",{"date":107,"type":21},"2027-09",{"name":109,"class":79},"Medical University of Warsaw",2]