Clinical trial on the use of Sodium Fluorescein for the surgical removal of High Grade Gliomas.

Phase 1

• Conditions: Intracranial high grade gliomas; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002527-18-IT
• Lead Sponsor: ISTITUTO NEUROLOGICO CARLO BESTA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-09
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a)Patients, both males and females, with an age between 18 and 75 years. b)Patients affected by probable first diagnosed high grade glioma, as suggested by a brain MR with and without intravenous paramagnetic contrast administration performed within 14 days before the surgical procedure. c)Patients considered eligible for complete surgical tumor removal. d)Patients undergone preoperative volumetric brain MR with intravenous paramagnetic contrast administration for neuronavigation. e)Preoperative KPS (Karnofsky performance scale) > 60.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

a)Tumors arising from basal ganglia, infratentorial, arising in the midline, multifocal. b)Tumors with wide non-contrast enhancing area suggesting low grade gliomas with secondary malignant transformation. c)Medical reasons that make the patient unsuitable to undergo brain MR. d)Cognitive or speech impairment that make the patient unable to give his/her consent. e)Previous malignant tumors in any other localizations still under therapy or anyway considered not cured. f)Known contrast allergy or previous anaphylactic shock. g)Renal failure. h)Hepatic failure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified