NCT01403311

A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Legacy Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.

Detailed description

This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection. Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	5-Aminolevuline Acid	5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2015-03-01
• First posted: 2011-07-27
• Last updated: 2014-03-26

Locations

1 site across 1 country: United States