Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-28 @ 5:32 AM
Study NCT ID:
NCT06160492
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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)
Sponsor:
Lee's Pharmaceutical Limited
Organization:
Study Overview
Official Title:
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)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: