Sonodynamic Therapy With ExAblate System in Glioblastoma Patients
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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".
Patients will be consented, screened, and will undergo study SDT treatment with 5-ALA using
the ExAblate Model 4000 Type-2 "Neuro-System". After SDT treatment, patients will perform a
strict neuro-radiological follow-up (minimum of 2 MRI) and undergo tumor resection 14-21 days
after SDT, according to the clinical and radiological status.
The main goal of the present study is to investigate the antitumor effects of SDT in patients
affected by HGGs attained with low-frequency focused ultrasound.
- Safety will be evaluated by patient examination and MRI during the treatment, and by
follow-up by daily clinical visits and MRI every 3 days. Data on the safety versus
adverse effects of this treatment will be acquired during each visit through a
combination of MRI evaluations, clinical assessments and neurological examinations.
- Feasibility will be evaluated performing serial MRI after SDT treatment evaluating tumor
size, morphology and peri-lesional edema until tumor resection.
Efficacy is not a primary endpoint. To evaluate the treatment effect, for each subject, the
following data will be collected:
- Tumor volume changes after SDT according to sonicated tumors volumes (by imaging).
- Histology after tumor resection, comprising assessment of apoptosis and necrosis.
Phase:
N/A
Details
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta