Investigational use of 5-ALA for fluorescence-guided resection of malignant glioma - ND
- Conditions
- Glioblastoma multiformeMedDRA version: 6.1Level: PTClassification code 10018336
- Registration Number
- EUCTR2006-002606-54-IT
- Lead Sponsor
- ASL SALERNO 1
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1 Malignant glioma affected patients 2 Karnofsky Performance Scale KPS score 60 3 30 70 yera-old patients 4 informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Porphyria, renal complications, creatinine 2mg/dl, bilirubin 3mg/dl, prothrombine time 60 , gammagluthamyltransferase 70 U/L
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Further improvement of surgical intervention by the intra-operative fluorescence-guided resection of residual malignant glioma, tested by early postoperative MR imaging;Secondary Objective: Improvement of the time to progression valued by postoperative magnetic resonance each 2 months and survival.;Primary end point(s): Residual glioma volume tested by early postoperative MR imaging 48 hours
- Secondary Outcome Measures
Name Time Method