Clinical trial · Interventional
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)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 5-aminolevulinic Acid | — | UNRESOLVED | — |
| Fluorescence-guided Resection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-aminolevulinic acid | Drug | 5-Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- test group
- description
- The test group was set to administer a dose of 20 mg/kg body weight, and 3 hours before anesthesia (range 2-4 hours), 5-ALA HCl was dissolved in drinking water and taken orally, after which they underwent fluorescence-guided resection of malignant gliomas
- interventionNames
- Drug: 5-aminolevulinic acid
- type
- NO_INTERVENTION
- label
- control group
- description
- The control group was operated by traditional white light microscope tumor resection, and all tumor tissues were removed as far as possible within the safety range. Cranial enhancement MRI was performed within 72h after surgery .
Primary outcomes (1)
- measure
- gross total resection rate(GTR rate)
- timeFrame
- Within 72 hours after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available