Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-04-11 @ 5:28 PM
Study NCT ID:
NCT01502605
Status:
TERMINATED
Last Update Posted:
2017-01-05
First Post:
2011-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI leaving institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA) (also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.
Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the tumor can look like normal brain tissue. Studies in other countries have shown that in some brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may make it easier for doctors to remove as much tumor as safely as possible from your brain.
This study also hopes to see if 5-ALA can find different cell populations within the tumor that is removed and allow the researchers to better understand brain tumors.
The purpose of this study is to:
* Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see how well 5-ALA can find different cell populations within brain tumors
* Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow under ultraviolet light
* Make sure the 5-ALA identifies tumor and not normal brain
* Make sure 5-ALA does not cause any side effects
Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the tumor can look like normal brain tissue. Studies in other countries have shown that in some brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may make it easier for doctors to remove as much tumor as safely as possible from your brain.
This study also hopes to see if 5-ALA can find different cell populations within the tumor that is removed and allow the researchers to better understand brain tumors.
The purpose of this study is to:
* Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see how well 5-ALA can find different cell populations within brain tumors
* Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow under ultraviolet light
* Make sure the 5-ALA identifies tumor and not normal brain
* Make sure 5-ALA does not cause any side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: