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Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM

Sponsor
InSightec (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04440358
Collaborator
(none)
50
Enrollment
4
Locations
1
Arm
29.6
Anticipated Duration (Months)
12.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 13, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Device: Exablate BBBD
BBB opening via Exablate Neuro Type 2 system to deliver carboplatin
Other Names:
  • Exablate Neuro

    • Drug: Carboplatin
    Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of Adverse Events [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

    2. Contrast intensity on MR imaging [Immediately after Exablate BBBD procedure]

      BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    2 Sheba Medical Center Tel Hashomer Israel 52621
    3 Fondazione IRCCS Neurologico Carlo Besta Milano Italy 20133
    4 Yonsei University Medical Center Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • InSightec

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InSightec
    ClinicalTrials.gov Identifier:
    NCT04440358
    Other Study ID Numbers:
    • BT009 [OUS]
    First Posted:
    Jun 19, 2020
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by InSightec
    Exablate
    Focused Ultrasound
    Carboplatin
    Additional relevant MeSH terms:
    Glioblastoma
    Carboplatin

    Study Results

    No Results Posted as of Dec 7, 2021