Recurrent Glioblastoma Clinical Trial
Official title:
Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
Verified date | March 2024 |
Source | InSightec |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
Status | Active, not recruiting |
Enrollment | 13 |
Est. completion date | July 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Must be between 18-80 years old - Histologically confirmed glioblastoma - Planned for Carboplatin monotherapy - Be willing and able to provided written informed consent/assent - Tumor progression after first line therapy - Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy - Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception - Able to communicate verbally Exclusion Criteria: - Acute intracranial hemorrhage - Ferrous metallic implanted objects in the skull or brain - Prior toxicity with carboplatin chemotherapy - Women who are pregnant or breastfeeding - Cerebellar spinal cord or brain stem tumor - Known active Hepatitis B or Hepatitis C or HIV - Significant depression not adequately controlled - Cardiac disease or unstable hemodynamics - Severe hypertension - History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage - Active drug or alcohol use disorder - Known sensitivity to gadolinium-based contrast agents - Known sensitivity or contraindications to ultrasound contrast agent or perflutren - Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices - Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication - Severely impaired renal function - Right to left or bi-directional cardiac shunt - Cranial or systemic infection requiring antibiotics - Known additional malignancy that is progression or require active treatment |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Italy | Fondazione IRCCS Neurologico Carlo Besta | Milano | |
Korea, Republic of | Yonsei University Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
InSightec |
Canada, Italy, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of Adverse Events | All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria | Through study completion, an average of 12 months | |
Primary | Contrast intensity on MR imaging | BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging | Immediately after Exablate BBBD procedure |
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