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Clinical Trials in China / NCT06160492
Recruiting 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 3/4)

NCT06160492 · tracked via the Priya Life Science China tracker
Sponsor
Lee's Pharmaceutical Limited
Phase
Phase 3
Started
2025-04-14
Last updated
2025-05-13

Condition(s) studied

5-aminolevulinic AcidFluorescence-guided Resection

Investigational drug(s) / intervention(s)

5-aminolevulinic acid

5-aminolevulinic acid: Patients were randomly assigned to 5-aminolevulinic acid (20 mg/kg 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.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
Henan Province Tumor Hospital Zhengzhou Henan Recruiting

More Lee's Pharmaceutical Limited trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06160492 on ClinicalTrials.gov ↗ ← All trials in China