DRKS00004966CompletedPhase 2
Clinical Phase II Trial of 5-Aminolevulinic Acid Hydrochloride (5-ALA, 5-ALS) for Fluorescence-Guided Resection of Malignant Glioma
medac, Gesellschaft für klinische Spezialpräparate mbH0 sites36 target enrollmentStarted: May 10, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •Suspected malignant glioma (WHO grades III or IV) according to MRI criteria
- •no prior tumor specific therapies
- •planned surgery
Exclusion Criteria
- •Porphyria or sensitivity to porphyrins
- •Renal or hepatic disease
- •Dementia or other cognitive disorders precluding informed consent
Investigators
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