Actively Recruiting
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)
Led by Lee's Pharmaceutical Limited · Updated on 2025-05-13
144
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of 5-aminolevulinic acid hydrochloride (5-ALA HCl) fluorescence-guided microsurgery compared to conventional white light microsurgery in patients with malignant gliomas (WHO grade 3/4). This phase III, randomized, open, parallel-group, multicenter study aims to assess how well these two surgical methods remove tumor tissue safely. Participants are randomly assigned to either the test group or the control group in equal numbers. The test group receives an oral dose of 5-ALA HCl at 20 mg/kg dissolved in drinking water 2 to 4 hours before anesthesia, followed by tumor removal guided by fluorescence microscopy. The control group undergoes traditional white light microscopic tumor resection. Both groups have cranial enhanced MRI scans within 72 hours after surgery to assess the extent of tumor removal. During the study, participants are monitored for adverse events starting 4 hours before the test drug administration or surgery and continuing through the postoperative safety follow-up. Researchers track the gross total resection rate within 72 hours after surgery as the primary outcome. They also evaluate the diagnostic rate of strongly fluorescent tissue biopsy specimens within 15 days post-surgery. Participants must comply with follow-up visits and assessments throughout the trial duration.
CONDITIONS
Brief 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 18-70 years of age, inclusive
- Patients with presumably new malignant gliomas (WHO grade 3/4) diagnosed by imaging
- Karnofsky Performance Status (KPS) score of 60 or higher
- Ability to take oral medications
- Laboratory test results within 7 days before surgery meeting specified limits for ALT, AST, GGT, total bilirubin, and creatinine
- Non-surgically sterilized or female subjects of childbearing potential must have a negative pregnancy test and be non-lactating
- Female subjects of childbearing potential and male subjects with partners of childbearing potential must use contraception for 3 months after drug administration
- Ability 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 5-aminolevulinic acid, aminoglutaric acid, porphyrins, or similar substances
- Acute or chronic porphyria or history of skin sensitivity disorders such as photosensitivity or dermatoses
- Tumor located in midline, basal ganglia, cerebellum, or brainstem
- Inability to undergo enhanced MRI due to devices, allergies, or other reasons
- Participation in other clinical trials or use of trial medications within 30 days before this study
- Uncontrolled heart conditions including certain classes of heart failure, severe angina, cardiomyopathy, recent heart attack or surgery, difficult-to-control hypertension, severe arrhythmias, or low heart ejection fraction
- Active hepatitis B or C unless well controlled, HIV positive, or history of AIDS
- Any other condition judged by the investigator to make participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive either 5-ALA HCl orally 2 to 4 hours before surgery followed by fluorescence-guided resection, or conventional white light microsurgery to remove malignant gliomas within a safe range.
1 surgical visit
Duration - Up to 15 days after surgery
Participants undergo cranial enhanced MRI within 72 hours after surgery and are monitored for adverse events from 4 hours before surgery until the end of the postoperative safety follow-up.
1 MRI visit and additional safety monitoring visits
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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