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).
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 were randomly divided into two groups and randomized 1:1. The test group received 5-ALA HCl administration + excision under fluorescence and the control group received excision under white light. 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. The light source is switched by the surgeon according to the intraoperative situation. Try to remove all tumor tissues within the safe range. The first 10 subjects in the test group underwent pharmacokinetic testing. Cranial enhanced MRI was performed within 72 h after surgery. In the control group, traditional white light microscopic tumor resection surgery was used, and pathological specimen tissues were retained according to pathological SOPs, and all tumor tissues were resected as far as possible within a safe range. Cranial enhancement MRI was performed within 72h after operation During the course of the trial, subjects were monitored for adverse events (AEs) from 4h prior to the administration/surgery of the test drug to the end of the postoperative safety follow-up period and recorded in the EDC, all AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
144
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.
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHenan Province Tumor Hospital
Zhengzhou, Henan, China
RECRUITINGgross 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
Time frame: Within 72 hours after surgery
Positive diagnostic rate of strongly fluorescent tissue biopsy specimens
Proportion of tissue specimens taken intraoperatively in the test group that were positive for tumor by pathological testing
Time frame: Within 15 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.