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 3/4)

ALA HCl-LEES-2022-01

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 3/4).

2024-02-01

2026-02-01

2026-03-01

Not yet recruiting

Early phase I

144

Inclusion Criteria: * Males or females 18-70 years of age, inclusive; * Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging; * have a Karnofsky Performance Status (KPS) ≥ 60; * Ability to take oral medications; * Laboratory tests meeting the following criteria within ≤ 7 days preoperatively: Alanine aminotransferase (ALT), Mentholatum aminotransferase (AST), Glutamyl transpeptidase (GGT) \< 100 IU/L; Serum total bilirubin (TBIL) \< 51.3 μmol/L (3.0 mg/dl); Serum creatinine (CRE) \< 176.8 μmol/L (2.0 mg/dl); * 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; * 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. Exclusion Criteria: * Known hypersensitivity to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs; * acute or chronic porphyria; history of cutaneous photosensitivity, actinic dermatoses, and exfoliative dermatitis * Tumor located in the midline, basal ganglia, cerebellum, or brainstem; * Inability to undergo enhanced MRI (pacemaker, contrast allergy, and other reasons); * 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; * Comorbid uncontrolled cardiac conditions such as: a) New York Heart Association (NYHA) class ≥II, b) severe/unstable angina, c) primary cardiomyopathy, d) myocardial infarction or previous coronary/peripheral 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 \<50%; * 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; * Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, open, parallel-group, multicenter, conventional treatment-controlled trial', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}

2023-12-08