[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528417":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":27,"responsibleParty":66,"collaborators":18,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":18,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":18,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":18,"overallStatus":53,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Lee's Pharmaceutical Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"test group","EXPERIMENTAL","The test group was set to administer a dose of 20 mg\u002Fkg body weight, and 3 hours before anesthesia (range 2-4 hours), 5-ALA HCl was dissolved in drinking water and taken orally, after which they underwent fluorescence-guided resection of malignant gliomas",[13],"Drug: 5-aminolevulinic acid",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","NO_INTERVENTION","The control group was operated by traditional white light microscope tumor resection, and all tumor tissues were removed as far as possible within the safety range. Cranial enhancement MRI was performed within 72h after surgery .",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","5-aminolevulinic acid","Patients were randomly assigned to 5-aminolevulinic acid (20 mg\u002Fkg bodyweight）Those randomly allocated to 5-aminolevulinic acid were scheduled to receive freshly prepared solutions of 5-aminolevulinic acid orally 3 h (range 2-4) before induction of anaesthesia. Solutions were prepared by dissolving the contents of a vial (1·5 g) in 50 mL of drinking water.",[9],[26],"5-ALA HCl",[28,51],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Sun Yat-Sen University Cancer Center","NOT_YET_RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":37,"coordinates":38},"Point",[39,40],113.25,23.11667,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":18,"email":47},"Zhongping Chen, doctor","CONTACT","+8613500002457","chenzhp@sysucc.org.cn",{"name":49,"role":45,"phone":18,"phoneExt":18,"email":50},"Deipei Li, doctor","guochch@sysucc.org.cn",{"facility":52,"status":53,"city":54,"state":55,"zip":18,"country":34,"countryCode":35,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Henan Province Tumor Hospital","RECRUITING","Zhengzhou","Henan",{"type":37,"coordinates":57},[58,59],113.64861,34.75778,{"lat":59,"lon":58},[62],{"name":63,"role":45,"phone":64,"phoneExt":18,"email":65},"zhenyan hao","15521091783","Yean_zone@163.com",{"type":67,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100528417","phase-3-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-34-100528417",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":79,"type":80},144,"ESTIMATED","INTERVENTIONAL",[83],"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).",[86,87],"5-aminolevulinic Acid","Fluorescence-guided Resection","2025-05-09",{"date":90,"type":91},"2025-05-13","ACTUAL",{"date":93,"type":91},"2025-04-14",{"date":95,"type":80},"2026-03",{"name":5,"class":6},2]