Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy

• ClinicalTrials.gov Identifier: NCT04417088
• Recruitment Status: Active, not recruiting
• First Posted: June 4, 2020
• Last Update Posted: March 5, 2024
• Sponsor: InSightec
• Information provided by (Responsible Party): InSightec

Tracking Information

• First Submitted Date: June 1, 2020
• First Posted Date: June 4, 2020
• Last Update Posted Date: March 5, 2024
• Actual Study Start Date: November 6, 2020
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 3, 2020)

• Adverse events [ Time Frame: Through study completion, an average of 12 months ]
  All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
• Contrast intensity on MR imaging [ Time Frame: Immediately after Exablate BBBD procedure ]
  BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
• Official Title: Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
• Brief Summary: 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.
• Detailed Description: This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system with microbubble resonators. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Recurrent Glioblastoma

Intervention

• Drug: Carboplatin
  Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
• Device: Exablate BBBD
  BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
  Other Name: Exablate Neuro

Study Arms

Experimental: Exablate BBBD with carboplatin

Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.

Interventions:

• Drug: Carboplatin
• Device: Exablate BBBD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 3, 2020): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2024
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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/asent
• Tumor progression after first line chemo radiation
• 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
• Has previously received anti-VEGF or anti-VEGF agents like Avastin
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04417088
• Other Study ID Numbers: BT009
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: InSightec
• Original Responsible Party: Same as current
• Current Study Sponsor: InSightec
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: InSightec
• Verification Date: March 2024