ALA fluorescence guided resections in malignant gliomas
Phase 1
- Conditions
- Health Condition 1: null- malignant gliomas
- Registration Number
- CTRI/2015/08/006122
- Lead Sponsor
- Intramural TMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Per-primum glioma
•Adults (18-65 years)
•Radiologically suspected malignant gliomas
•Variable contrast enhancement on MRI (patchy and/or non-uniform)
•Eligible for surgical therapy (craniotomy NOT stereotactic biopsy )
•No contraindication for surgery
Exclusion Criteria
•Poor general condition (KPS < 70)
•Prior treatment (except biopsy)
•Compromised renal/hepatic function.
•Immunocompromised status
•Known photosensitivity / allergy to 5-ALA
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Degree of fluorescence in different tumor regions. <br/ ><br>2. PPIX quantificationTimepoint: NA
- Secondary Outcome Measures
Name Time Method 1. Proteomics differences in variably fluorescing regions.Timepoint: NA