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Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04998864
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	InSightec
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Unknown status
Countries	Italy, Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Malignant, Glioblastoma

Additional Details

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

Arms & Interventions

Arms

: Focused Ultrasound (FUS) BBB Disruption

The Exablate Model 4000 Type 2.0 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing standard of care chemotherapy.

Interventions

Device: - Magnetic Resonance guided Focused ultrasound (MRgFUS)

FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fondazione IRCCS Neurologico Carlo Besta, Milano, Italy

Status

Recruiting

Address

Fondazione IRCCS Neurologico Carlo Besta

Milano, , 20133

Site Contact

Dott.ssa Giorgia Simonetti

[email protected]

+39 022394-2443

CINAC-Hospital HM Puerta del Sur, Móstoles, Madrid, Spain