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NCT01116661 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
NCT01116661: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT01116661 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 199 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116661, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
Study Summary
The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.
Primary Outcome
Biopsies were examined by a pathologist to determine the amount of tumor content from the most fluorescent tissues
Interventions
- DRUG 5-Aminolevuline Acid (ALA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2010-08 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 2 |
Why NCT01116661 stopped before completion
NCT01116661 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which 5-Aminolevuline Acid (ALA) is the first listed.
NCT01116661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116661 about?
NCT01116661 is a clinical study titled "Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain". The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to ...
What is the current status of trial NCT01116661?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2010-08. Estimated completion is 2019-02-28.
What interventions are being tested in trial NCT01116661?
The interventions under investigation include: 5-Aminolevuline Acid (ALA) (DRUG).
Who is sponsoring clinical trial NCT01116661?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116661's enrollment target sits among peer trials
199 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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