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Clinical Trials/EUCTR2021-003374-30-IT
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

FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA0 sites10 target enrollmentOctober 19, 2021
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.

Registry
who.int
Start Date
October 19, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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