Clinical Phase II Trial of 5-Aminolevulinic Acid Hydrochloride (5-ALA, 5-ALS) for Fluorescence-Guided Resection of Malignant Glioma
Phase 2
- Conditions
- C71.9Brain, unspecified
- Registration Number
- DRKS00004966
- Lead Sponsor
- medac, Gesellschaft für klinische Spezialpräparate mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Suspected malignant glioma (WHO grades III or IV) according to MRI criteria
KPS >60
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of the positive predictive value of tissue fluorescence, defined as the fraction of patients in whom all biopsies taken from fluorescing tissue truly show tumor infiltration.
- Secondary Outcome Measures
Name Time Method 1. Determination of the positive predictive value of fluorescence based on biopsies<br>2. Correlation of visible fluorescence to spectrometrical fluorescence and histology<br>3. Determination of whether visible fluorescence simplifies resection<br>4. Correlation of residual fluorescing tissue left unresected with early post-operative magnetic resonance imaging<br>5. Determination of toxicity according to standardized toxicity criteria (NCI Common Toxicicty Criteria CTC, [Version 1.0, modifiziert nach German Phase I, II, III Study Groups, New Drug Development Group (AWO) and Study Group of Pharmacology in Oncology and Hematology (APOH) of the Association for Medical Oncology (AIO) of the German Cancer Society)