| Title |
A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study |
| Description |
5-Aminolevulinic acid (5-ALA) is a naturally occurring metabolite in the body's heme synthesis pathways. In tumor cells, the enzyme pathway is either missing or ineffective, instead converting the ALA to porphyrin compounds that fluoresce in the 620-720 nm range when excited by incident light of 400-410 nm. In this study, an operative microscope will be modified with filters to allow these specific wavelengths of light to be used for excitation and a photomultiplier/filter arrangement, allowing the fluoresced light to be detected in real time in order to increase the amount of tumor visualized, and ultimately resected, to increase the post-operative tumor free survival time. |
| Drug/Procedure |
Gliolan/Fluorescence-guided surgery |
| NCT Number |
02632370 |
| Notes |
In a prior randomized clinical trial completed in Europe, patients who underwent fluorescence-guided surgery after 5-ALA administration did have a significant benefit in comparison to patients who underwent removal of their tumor without 5-ALA and standard resection. Those patients had a more complete removal of their malignant brain tumor and also had a delay in the regrowth of their tumor at 6 months after surgery. Additional information can be found at ClinicalTrials.gov |
| Start Date |
11/01/2015 |
| Status |
Data analysis; closed to enrollment |
| Principal Name |
Bruce Andersen, MD, PhD, FACS, FAANS |
| Contact Name |
Terra Inman, CCRC |
| Phone |
(208)367-7397 |
