Evaluation of fluoroscein as contrast medium for glioma surgery
Phase 1
- Conditions
- GlioblastomaMedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-003402-16-IT
- Lead Sponsor
- FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
• Have given written informed consent to participate
• Be aged 18 years and over
• Suspected diagnosis of High Grade Glioma on pre-op (<7 days) c.e. MRI
• Surgeon's evaluation of the lesion as amenable of GTR
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
Exclusion Criteria
• Known allergy to contrast media
• Pregnancy
• Renal failure (creatinine > 1.5 mg/dL)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Within 72 hours after surgery;Main Objective: Improve the rate of success of surgical interventions on GMB maximizing the resection and minimizing the unnecessary damage.;Secondary Objective: Evaluate the Progression Free survival of the patients, the Overall Survival, the advent of new neurological deficits and the quality of life of the patients.;Primary end point(s): The rate of GTR on post op c.e. Radiological assesments
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression free survival (PFS); Overall survival; Neurological performances and quality of life;Timepoint(s) of evaluation of this end point: End of study; End of study; End of study