EUCTR2021-003374-30-IT
Active, not recruiting
Phase 1
A pilot study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas. - SONIC-ALA
DrugsGLIOLAN
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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