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| Sponsor: | medac GmbH |
|---|---|
| Information provided by: | medac GmbH |
| ClinicalTrials.gov Identifier: | NCT00241670 |
Purpose
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 |
|---|---|---|
|
Brain Cancer Brain Tumors Cancer of Brain Primary Brain Tumors Brain Tumor, Primary |
Drug: 5-aminolevulinic acid |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00241670 History of Changes |
| Other Study ID Numbers: | MC-ALS.3/GLI |
| Study First Received: | October 18, 2005 |
| Last Updated: | October 18, 2005 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Brain Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Aminolevulinic Acid Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses |