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)
Recruiting now · Phase 3
Conditions studied: 5-aminolevulinic Acid, Fluorescence-guided Resection
In brief
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).
Key facts
- Study ID
- NCT06160492
- Run by
- Lee's Pharmaceutical Limited
- People needed
- 144
- Starts
- 2025-04-14
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-05-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Henan Province Tumor Hospital — Zhengzhou, Henan, China (enrolling)
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China
Full record on ClinicalTrials.gov
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