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)

Trial ID: NCT06160492

Interventional - Phase 3 - Recruiting

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).

Conditions

• 5-aminolevulinic Acid
• Fluorescence-guided Resection

Interventions

• 5-aminolevulinic acid

Eligibility

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;

Sponsor

Lee's Pharmaceutical Limited

Source: ClinicalTrials.gov

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