Status:
COMPLETED
Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
Lead Sponsor:
medac GmbH
Collaborating Sponsors:
IKP
Conditions:
Brain Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed ma...
Eligibility Criteria
Inclusion
- Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
- Indication for surgical tumour resection
- First operation of the tumour, no other tumour-specific pre-treatment
- Karnofsky Performance Scale 70%
- Patient's written informed consent
- Age 18-75 years
Exclusion
- Porphyria, hypersensitivity to porphyrins
- Renal insufficiency:
- Creatinine \> 2.0 mg/dl
- Hepatic insufficiency:
- Bilirubin \> 3 mg/dl
- Quick test \< 60 %
- GT \> 100 U/I
- Other known malignancy (except basaliomas)
- Women:
- Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)
- Men:
- Inadequate contraception (condom)
- Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
- Simultaneous participation or participation in another clinical trial in the preceding 30 days
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2001
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02755142
Start Date
February 1 2000
End Date
June 1 2001
Last Update
May 23 2016
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