NCT04440358

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Typical duration for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 13, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

June 17, 2020

Last Update Submit

January 16, 2026

Conditions

Recurrent Glioblastoma

Keywords

ExablateFocused UltrasoundCarboplatin

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Exablate BBBD with carboplatin

EXPERIMENTAL

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 BBBDDrug: Carboplatin

Interventions

Exablate BBBDDEVICE

BBB opening via Exablate Neuro Type 2 system to deliver carboplatin

Also known as: Exablate Neuro
Exablate BBBD with carboplatin
CarboplatinDRUG

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

Exablate BBBD with carboplatin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Fondazione IRCCS Neurologico Carlo Besta

Milan, 20133, Italy

Location

Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

October 13, 2020

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

KR(1)CA(1)IT(1)