Intracranial high grade gliomas
Conditions
Interventions
Trade Name: FLUORESCEINA SODICA MON*IV 10F
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLUORESCEINA SODICA 1 g 5 ml (20%)
Current Sponsor code: NA
Other descriptive name: NA
Conce
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of preoperative intravenous injection of sodium fluorescein during surgery for high grade gliomas and to evaluate fluorescein capability to improve intraoperative visualization of tumor’s margins thus allowing a complete tumor resection.;Secondary Objective: To analyze the Progression Free Survival (PFS) at 6 and 12 months, the overall survival (OS) and the volume of residual tumor in cases of partial resection in a population of patients affected by high grade gliomas treated with image-guided surgical tumor excision plus intraoperative tumor visualization with sodium fluorescein, followed by postoperative concomitant chemotherapy and radiotherapy. Moreover, to evaluate the possible presence and seriousness of new postoperative neurological deficits.;Primary end point(s): The percentage of patient affected by istopathologic confirmed high grade glioma without residual paramagnetic contrast enhancing at early (within 72 hours) postoperative MR (100% complete resection).;Timepoint(s) of evaluation of this end point: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a)PFS (progression free survival) at 6 and 12 months. b)Volume of residual tumor at postoperative MR in cases of partial resection. c)OS (overall survival). d)Presence and seriousness of new postoperative neurological deficits. e)Toxicity.;Timepoint(s) of evaluation of this end point: 42 months | — |
Countries
Italy
Contacts
Public ContactServizio Ricerca e Sviluppo Clinico
Fondazione IRCCS Istituto Neurologico Carlo Besta
Outcome results
None listed