NCT00241670

Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Detailed description

Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively. Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.

Conditions

• Brain Cancer
• Brain Tumors
• Cancer of Brain
• Primary Brain Tumors
• Brain Tumor, Primary

Interventions

Type	Name	Description
DRUG	5-aminolevulinic acid (5-ALA)	1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery

Timeline

• Start date: 1999-10-01
• Primary completion: 2004-07-01
• First posted: 2005-10-19
• Last updated: 2012-04-26