Brain Cancer Clinical Trial
Official title:
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
Verified date | April 2012 |
Source | medac GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 415 |
Est. completion date | |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 72 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
medac GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Within 72 hours after surgery | No | |
Primary | 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). | Within 6 month after surgery | No | |
Secondary | 1. Overall survival. | Until 18 months after surgery | No | |
Secondary | 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment | Until 18 months after surgery | No | |
Secondary | 3. Volume of residual tumour | After surgery | No | |
Secondary | 4. Toxicity after oral administration of 5-Aminolevulinic acid. | Until 18 month after surgery | Yes | |
Secondary | 5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment | Until 18 month after surgery | No |
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