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Sonodynamic Therapy with ExAblate System in Glioblastoma Patients

NCT04845919 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-11-12

No results posted yet for this study

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 15-21 days after SDT, according to the clinical and radiological status.

The main goal of the present study is to investigate the safety and feasibility of SDT in patients affected by GBMs attained with low-frequency FUS.

In particular:

Safety will be evaluated by patient examination and MRI images during the treatment, and by follow-up MRI and clinical and neurological visits.

To evaluate feasibility, the extent of the sonicated area will be calculated at the end of the procedure in order to evaluate the targeted area.

Secondary objective of the trial is to assess the efficacy of the SDT procedure in terms of tumor regression and/or cell apoptosis and necrosis.

Conditions

Interventions

DRUG

5-Aminolevulinic Acid

SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 "Neuro-System".

Sponsors & Collaborators

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-22
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04845919 on ClinicalTrials.gov