Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
18 Years
72 Years
Both
Brain Cancer, Brain Tumors, Cancer of Brain, Primary Brain Tumors, Brain Tumor, Primary
Trial Information
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
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).
Outcome Time Frame:
Within 72 hours after surgery
Safety Issue:
No
Principal Investigator
Hans-Juergen Reulen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ludwig-Maximilians - University of Munich
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
MC-ALS.3/GLI
NCT ID:
NCT00241670
Start Date:
October 1999
Completion Date:
Related Keywords:
- Brain Cancer
- Brain Tumors
- Cancer of Brain
- Primary Brain Tumors
- Brain Tumor, Primary
- Brain Neoplasms
- Glioma
Name | Location |
|---|
