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

Last updated: April 25, 2012
Sponsor: medac GmbH
Overall Status: Completed

Phase

3

Condition

Neurofibromatosis

Astrocytoma

Brain Cancer

Treatment

N/A

Clinical Study ID

NCT00241670
MC-ALS.3/GLI
  • Ages 18-72
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Radiological suspicion of a unilocular malignant glioma with distinct ring- orgarland-shaped contrast agent-accumulating tumour structures and a core of reducedintensity 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, thelocation 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

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 orextracerebral 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 anotherclinical trial in the 30 days preceding randomisation

Study Design

Total Participants: 415
Study Start date:
October 01, 1999
Estimated Completion Date:

Study 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.