IV degree lobar glioblastoma with a diameter of less than 5 cm. MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GLIOLAN
Product Name: GLIOLAN
Product Code: [EU/1/07/413/001-003]
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: acido 5-aminolevulinico
CAS Number: 5451-09-2
Current S
Sponsors
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria Inclusion: CH patients - age between 18-60 years; - both genders; - diagnosis of grade IV lobar glioblastoma with a diameter of less than 5 cm; - diagnosis confirmed with magnetic resonance examination; - no contraindication to the magnetic resonance examination; - no contraindications to surgery. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Brain glioblastoma presenting with the following characteristics: ¿ Brain edema and/or mass effect that causes midline shift of more than 10 mm ¿ Evidence of recent intracranial hemorrhage within the targeted tumor volume ¿ Calcifications in the focused ultrasound sonication path (system tools may not tailor the treatment around these calcifications) 2. The sonication pathway to the tumor involves either: ¿ more than 30% of the skull area traversed by scars, scalp disorders (e.g. eczema), or atrophy of the scalp ¿ Clips, shunts, or other metallic implanted objects in the skull or the brain 3. Cardiac disease or unstable hemodynamic status including: ¿ Documented myocardial infarction within six months of enrolment ¿ Unstable angina on medication ¿ Congestive heart failure ¿ Left ventricular ejection fraction 1.3 8. Cerebral or systemic vasculopathy 9. Known allergy sensitivity or contraindications to gadolinium 10. Contraindications to MRI such as non-MRI-compatible implanted devices 14 11. Subjects not fitting comfortably into the MRI scanner 12. Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia 13. Positive pregnancy test (for pre-menopausal women) 14. Severely impaired renal function with estimated glomerular filtration rate <30mL/min/1.73m2 and/or on dyalisis 15. Respiratory: chronic pulmonary disorders, e.g. severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. 16. Any illness or medical condition that in the investigator’s opinion precludes participation in this study 17. Patients unable to sign a consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of this prospective, non-randomized, single-arm study is to evaluate the safety and feasibility of sonodynamic therapy with 5-aminolevulinic acid in patients with newly diagnosed cerebral glioblastomas using the ExAblate Model 4000 Type-2 “Neuro-System”.;Secondary Objective: Efficacy of the treatment, the following data will be collected for each subject: - Overall tumor volume (for images) - Immunohistochemical staining dedicated to the detection of cellular apoptosis and necrosis, as well as angiogenesis and inflammation;Primary end point(s): safety;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactDipartimento Ricerca e Sviluppo Cli
Fondazione Istituto Neurologico Carlo Besta
Outcome results
None listed