NCT01351519

A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: MultiCare Health System Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

Detailed description

This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.

Conditions

• Malignant Glioma
• Glioma
• Glioblastoma
• Glioblastoma Multiforme
• Astrocytoma

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid	Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-05-11
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States