Clinical trial NCT04998864: Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients
Official title: Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma, Malignant
Glioblastoma
Keywords: Glioma, MRgFUS, Exablate, TMZ
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2021-08-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with glioblastoma brain tumor who will undergo surgical resection and chemotherapy as standard of care with temozolomide.

Brief summary: The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.

Detailed description: The primary objective is to evaluate the safety and feasibility of BBB disruption using the Exablate Type 2.0 system in adult patients with glioblastoma (GBM) undergoing adjuvant TMZ chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care

Eligibility criteria: Inclusion Criteria:

1. Patient is eligible for adjuvant TMZ treatment.
2. Men or women age between 18 and 80 years, inclusive.
3. Able and willing to give informed consent.
4. Grade IV glioma (GBM) confirmed Subjects
5. Karnofsky rating 70-100.
6. Able to communicate during the Exablate BBBD procedure.
7. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Evidence of acute intracranial hemorrhage.
2. The subject presents with severe symptoms and signs of increased intracranial pressure
3. Patients with cerebellar or brainstem tumors.
4. Patients with positive HIV status
5. Patients with brain tumors containing 1p/19q chromosomal co-deletion
6. Patient receiving bevacizumab (Avastin) therapy
7. Patients undergoing other concurrent therapies
8. Cardiac disease or unstable hemodynamics
9. Severe hypertension
10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment
11. History of a bleeding disorder and/or coagulopathy
12. Known sensitivity to gadolinium-based contrast agents
13. Known sensitivity to ultrasound contrast agent
14. Severely impaired renal function
15. Subjects with significant liver dysfunction

Primary outcomes:
measure: Device and procedure related adverse events
timeFrame: Throughout the study, approximately 12 months.
measure: Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging
timeFrame: At the time of each ExAblate MRgFUS procedure]
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Neurologico Carlo Besta
city: Móstoles
country: Spain
facility: CINAC-Hospital HM Puerta del Sur
state: Madrid
Study officials:
References: