Status:
COMPLETED
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
Lead Sponsor:
medac GmbH
Conditions:
Brain Cancer
Brain Tumors
Eligibility:
All Genders
18-72 years
Phase:
PHASE3
Brief 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 tumou...
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 bu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00241670
Start Date
October 1 1999
Last Update
April 26 2012
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