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Sponsored by: |
medac GmbH |
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Information provided by: | medac GmbH |
ClinicalTrials.gov Identifier: | NCT00241670 |
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.
Condition | Intervention | Phase |
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Brain Cancer Brain Tumors Cancer of Brain Primary Brain Tumors Brain Tumor, Primary |
Drug: 5-aminolevulinic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) Vs. Conventional Resection |
Estimated Enrollment: | 270 |
Study Start Date: | October 1999 |
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.
Ages Eligible for Study: | 18 Years to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | MC-ALS.3/GLI |
Study First Received: | October 18, 2005 |
Last Updated: | October 18, 2005 |
ClinicalTrials.gov Identifier: | NCT00241670 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Aminolevulinic Acid Brain Neoplasms Neuroectodermal Tumors Photosensitizing Agents |
Radiation-Sensitizing Agents Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Pharmacologic Actions Aminolevulinic Acid Brain Neoplasms Neuroectodermal Tumors |
Photosensitizing Agents Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Dermatologic Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |