Status:
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)
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
5-aminolevulinic Acid
Fluorescence-guided Resection
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 lig...
Detailed Description
As specified in the trial procedure, patients entered the screening period after signing an informed consent form, and subjects who met the inclusion criteria and did not meet the exclusion criteria w...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06160492
Start Date
April 14 2025
End Date
March 1 2026
Last Update
May 13 2025
Active Locations (2)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000
2
Henan Province Tumor Hospital
Zhengzhou, Henan, China