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NCT01502280 · ClinicalTrials.gov registry record · Phase 3
Fluorescence-guided Surgery for Low- and High-grade Gliomas
A Phase 3 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 127
- Enrollment target
NCT01502280 is a Phase 3 study that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 127 participants.
The verdict
NCT01502280, a Phase 3 study, has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 127 participants
- Enrollment target
Study Summary
Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat. Mounting evidence suggests that survival improves with greater tumor removal, yet being able do a complete removal can be difficult due to the tumor's infiltrating nature. 5-aminolevulinic acid (5-ALA) is a natural compound that, when patients take it by mouth 3 hours before surgery, is selectively taken up by glioma cells and causes a red/pink fluorescence (glow) under a blue light that allows tumor margins to be seen during the course of surgery. While this compound is used as a standard-of-care agent in Europe, it remains under testing by the Food and Drug Administration (FDA). A recent clinical trial in Germany, however, has demonstrated a significant improvement in the rate of complete resection for certain brain tumors (65% vs. 34%). The Barrow 5-ALA Intraoperative Confocal (BALANCE) Trial will measure the effect of 5-ALA on the amount of glioma tumor removal. To improve the usefulness of 5-ALA, a new special microscope fitted with a blue light, will be used to magnify microscopic fluorescence at the tumor margins. The investigators' hypothesis is that 5-ALA fluorescence with the use of the special microscope during surgery will greatly lower the amount of tumor left behind.
Interventions
- DRUG 5-Aminolevulinic acid (ALA)
- DRUG Placebo - ascorbic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2010-11 |
| Est. Completion | 2018-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01502280
The ClinicalTrials.gov registry entry for NCT01502280 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 5-Aminolevulinic acid (ALA) is the first listed.
NCT01502280 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01502280 about?
NCT01502280 is a clinical study titled "Fluorescence-guided Surgery for Low- and High-grade Gliomas". Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat. Mounting evidence suggests that survival improves with greater tumor removal, yet being able do a complete removal can be difficult due to the tumor's infiltrating nature. 5-aminolevulinic acid (5-ALA) is a...
What is the current status of trial NCT01502280?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2010-11. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01502280?
The interventions under investigation include: 5-Aminolevulinic acid (ALA) (DRUG), Placebo - ascorbic acid (DRUG).
Who is sponsoring clinical trial NCT01502280?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
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