NCT04440358CompletedPhase 1/2
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 17 Jun 2020
- Start date
- 13 Oct 2020
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- InSightec
- Diseases
- Glioblastoma
- NCT number
- NCT04440358
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 13
- From 13 Oct 2020 to the primary completion date, 30 Nov 2023
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior toxicity with carboplatin chemotherapy
- Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
Other illness
- Acute intracranial hemorrhage
- Known active Hepatitis B or Hepatitis C or HIV
- 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
- Right to left or bi-directional cardiac shunt
- Cranial or systemic infection requiring antibiotics
- Known additional malignancy that is progression or require active treatment
Other
- Ferrous metallic implanted objects in the skull or brain
- Women who are pregnant or breastfeeding
- Cerebellar spinal cord or brain stem tumor
- Significant depression not adequately controlled
- 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
- Severely impaired renal function
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Fondazione IRCCS Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Yonsei University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.