Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
NCT ID: NCT02755142
Last Updated: 2016-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2000-02-29
2001-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Dose level 1
0,2 mg/Kg
Gliolan
Dose level 2
2,0 mg/Kg
Gliolan
Dose level 3
20 mg/Kg
Gliolan
Interventions
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Gliolan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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IKP
UNKNOWN
medac GmbH
INDUSTRY
Responsible Party
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Other Identifiers
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MC-ALS.8-I/GLI
Identifier Type: -
Identifier Source: org_study_id
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