[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"5-aminolevulinic-acid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:5-aminolevulinic-acid":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100528417",false,"NCT06160492","Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3\u002F4)","Phase III Clinical Trial Evaluating the Efficacy of 5-aminolevulinic Acid (5-ALA HCl) Fluorescence-guided Microsurgery Versus Conventional White Light Microsurgical Resection in Patients With Malignant Gliomas (WHO Grade 3\u002F4)","Inclusion Criteria:\n\n* Males or females 18-70 years of age, inclusive;\n* Patients with presumably new malignant gliomas (WHO grade 3\u002F4) diagnosed by imaging;\n* have a Karnofsky Performance Status (KPS) ≥ 60;\n* Ability to take oral medications;\n* Laboratory tests meeting the following criteria within ≤ 7 days preoperatively:\n\nAlanine aminotransferase (ALT), Mentholatum aminotransferase (AST), Glutamyl transpeptidase (GGT) \\\u003C 100 IU\u002FL; Serum total bilirubin (TBIL) \\\u003C 51.3 μmol\u002FL (3.0 mg\u002Fdl); Serum creatinine (CRE) \\\u003C 176.8 μmol\u002FL (2.0 mg\u002Fdl);\n\n* Non-surgically sterilized or female subjects of childbearing potential need to have a negative serum pregnancy test result and must be non-lactating females; female subjects of childbearing potential and male subjects whose spouses are of childbearing potential are voluntarily using contraception for a period of 3 months after administration of the test drug;\n* Subjects are able to understand the informed consent form, voluntarily participate and sign the informed consent form, have good compliance, and cooperate with follow-up visits.\n\nExclusion Criteria:\n\n* Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs;\n* acute or chronic porphyria; history of cutaneous photosensitivity, actinic dermatoses, and exfoliative dermatitis\n* Tumor located in the midline, basal ganglia, cerebellum, or brainstem;\n* Inability to undergo enhanced MRI (pacemaker, contrast allergy, and other reasons);\n* Subjects taking other trial medications within 30 days prior to the start of this trial or subjects undergoing other clinical trials at the same time;\n* Comorbid uncontrolled cardiac conditions such as: a) New York Heart Association (NYHA) class ≥II, b) severe\u002Funstable angina, c) primary cardiomyopathy, d) myocardial infarction or previous coronary\u002Fperipheral artery bypass grafting within ≤6 months prior to the procedure, e) difficult-to-control hypertension, f) severe arrhythmia requiring medication or intervention, and g) screening echocardiographic left ventricular ejection fraction \\\u003C50%;\n* Active hepatitis B or C (unless HBV-DNA titers below the minimum detection limit and HCV-RNA negative on antiviral therapy can be included), HIV-positive or known history of acquired immunodeficiency syndrome;\n* Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;","ALL","18 Years","70 Years",{"count":19,"type":20},144,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, open, parallel-group, multicenter clinical trial evaluating 5-aminolevulinic acid (5-ALA HCl) oral solution with powdered fluorescent microscopic tumor resection versus white light microscopic tumor resection in patients with malignant gliomas (WHO grade 3\u002F4).",[26,27],"5-aminolevulinic Acid","Fluorescence-guided Resection","RECRUITING","2025-05-09",{"date":31,"type":32},"2025-05-13","ACTUAL",{"date":34,"type":32},"2025-04-14",{"date":36,"type":20},"2026-03",{"name":38,"class":39},"Lee's Pharmaceutical Limited","INDUSTRY",2,""]