Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-27
Brief Title:
Phase III Clinical Trial Evaluating the Efficacy and Safety of 5-aminolevulinic Acid 5-ALA
Sponsor:
Lees Pharmaceutical Limited
Organization:
Lees Pharmaceutical Limited
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 34
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 34
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 11 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 mgkg 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 60h-72h 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 60h-72h
During the course of the trial subjects were monitored for adverse events AEs from 4h prior to the administrationsurgery 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 v50
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 60h-72h
During the course of the trial subjects were monitored for adverse events AEs from 4h prior to the administrationsurgery 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 v50
Study Oversight
Has Oversight DMC:
None
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?:
None