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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: Clinical Trial Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
It will be considered as a serious adverse event with possible, probable, and definitely attribution to 5-ALA (SAE, detailed in section 8) if (within 2 weeks of dosing): Grade 1 or 2 LFT abnormalities not resolving within 2 weeks A single documented Grade 3 or 4 LFT abnormalities A Grade 3 or 4 skin photosensitivity
Interventions
- DRUG 5-Aminolevulinic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
Why NCT01502605 stopped before completion
NCT01502605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Aminolevulinic Acid is the first listed.
NCT01502605 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01502605's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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