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

Primary Purpose

Recurrent Glioblastoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Exablate BBBD
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring Exablate, Focused Ultrasound, rGBM

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University of Maryland
  • Brigham and Women's Hospital
  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exablate BBBD with carboplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse events
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Contrast intensity on MR imaging
BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging

Secondary Outcome Measures

Full Information

First Posted
June 1, 2020
Last Updated
October 12, 2023
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT04417088
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
Exablate, Focused Ultrasound, rGBM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exablate BBBD with carboplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
Intervention Type
Device
Intervention Name(s)
Exablate BBBD
Other Intervention Name(s)
Exablate Neuro
Intervention Description
BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
Primary Outcome Measure Information:
Title
Adverse events
Description
All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
Time Frame
Through study completion, an average of 12 months
Title
Contrast intensity on MR imaging
Description
BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
Time Frame
Immediately after Exablate BBBD procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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