Actively Recruiting
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)
Led by Lee's Pharmaceutical Limited · Updated on 2025-05-13
144
Participants Needed
2
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years
- Diagnosed with presumably new malignant gliomas (WHO grade 3/4) by imaging
- Karnofsky Performance Status (KPS) of 60 or greater
- Able to take oral medications
- Laboratory tests within 7 days before surgery showing ALT, AST, GGT less than 100 IU/L; total bilirubin less than 51.3 bcmol/L (3.0 mg/dl); serum creatinine less than 176.8 bcmol/L (2.0 mg/dl)
- Non-surgically sterilized or, if female and of childbearing potential, have a negative pregnancy test and are not breastfeeding
- Use contraception voluntarily for 3 months after receiving the test drug if of childbearing potential (female participants or male participants with partners of childbearing potential)
- Able to understand and voluntarily sign the informed consent form, comply with study procedures, and attend follow-up visits
You will not qualify if you...
- Known allergy to the test drug ingredients, aminoglutaric acid, porphyrins, or their analogs
- History of acute or chronic porphyria, cutaneous photosensitivity, actinic dermatoses, or exfoliative dermatitis
- Tumor located in midline, basal ganglia, cerebellum, or brainstem
- Unable to undergo enhanced MRI due to pacemaker, contrast allergy, or other reasons
- Participation in another clinical trial or use of other trial medications within 30 days before this trial
- Uncontrolled cardiac conditions including NYHA class II or higher, severe angina, primary cardiomyopathy, recent myocardial infarction or bypass surgery within 6 months, difficult-to-control hypertension, severe arrhythmia requiring treatment, or left ventricular ejection fraction below 50%
- Active hepatitis B or C unless virus levels are controlled, HIV-positive, or history of AIDS
- Any other condition judged by the investigator to make trial participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
2
Henan Province Tumor Hospital
Zhengzhou, Henan, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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