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Fluorescence-Guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
This study has been completed.
First Received: October 18, 2005   No Changes Posted
Sponsored by: 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

MedlinePlus related topics: Brain Cancer Cancer Surgery
Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride
U.S. FDA Resources
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

Further study details as provided by medac GmbH:

Primary Outcome Measures:
  • 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV –WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
  • 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV –WHO).

Secondary Outcome Measures:
  • 1. Overall survival.
  • 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
  • 3. Volume of residual tumour
  • 4. Toxicity after oral administration of 5-Aminolevulinic acid.
  • 5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment

Estimated Enrollment: 270
Study Start Date: October 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).
  • Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.
  • First operation of the tumour, no other tumour-specific pretreatment
  • Karnofsky at least 70 %
  • Patient’s written informed consent
  • Age 18-72 years

Exclusion Criteria:

  • Tumour location in the midline, basal ganglia, cerebellum or brain stem
  • More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases
  • Porphyria, hypersensitivity to porphyrins
  • Renal insufficiency: Creatinine > 2.0 mg/dl
  • Hepatic insufficiency: Bilirubin > 3 mg/dl
  • Quick test < 60 %
  • gamma-GT > 70 U/I
  • Malignancies other than basaliomas
  • Existing or planned pregnancy or lactation, or inadequate contraception
  • Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241670

Sponsors and Collaborators
medac GmbH
Investigators
Study Chair: Hans-Juergen Reulen, MD Ludwig-Maximilians - University of Munich
  More Information

No publications provided by medac GmbH

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009