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)

NCT06160492 | Recruiting Phase 3

• 1 other identifier: ALA HCl-LEES-2022-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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 light microscopic tumor resection in patients with malignant gliomas (WHO grade 3/4).

Conditions

5-aminolevulinic Acid; Fluorescence-guided Resection

Outcome Measures

Primary Outcomes (1)

• gross total resection rate(GTR rate）

  Proportion of subjects in the test and control groups whose tumors were determined to have met the criteria for complete resection by cranial enhancement MRI within 72 hours postoperatively

  Within 72 hours after surgery

Secondary Outcomes (1)

• Positive diagnostic rate of strongly fluorescent tissue biopsy specimens

  Within 15 days after surgery

Study Arms (2)

test group

EXPERIMENTAL

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

Drug: 5-aminolevulinic acid

control group

NO INTERVENTION

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 .

Interventions

5-aminolevulinic acid DRUG

Patients were randomly assigned to 5-aminolevulinic acid (20 mg/kg bodyweight）Those randomly allocated to 5-aminolevulinic acid were scheduled to receive freshly prepared solutions of 5-aminolevulinic acid orally 3 h (range 2-4) before induction of anaesthesia. Solutions were prepared by dissolving the contents of a vial (1·5 g) in 50 mL of drinking water.

Also known as: 5-ALA HCl

test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (2)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Henan Province Tumor Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

Aminolevulinic Acid

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open, parallel-group, multicenter, conventional treatment-controlled trial

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 7, 2023
• Study Start: April 14, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)