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NCT01502605 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01502605 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 6 participants.
The verdict
NCT01502605, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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
Interventions
- DRUG 5-Aminolevulinic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01502605
The ClinicalTrials.gov registry entry for NCT01502605 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5-Aminolevulinic Acid is the first listed.
NCT01502605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01502605 about?
NCT01502605 is a clinical study titled "Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas". 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 su...
What is the current status of trial NCT01502605?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01502605?
The interventions under investigation include: 5-Aminolevulinic Acid (DRUG).
Who is sponsoring clinical trial NCT01502605?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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