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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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/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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04440358
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 InSightec
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries Canada, Italy, Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma
Additional Details

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.

Arms & Interventions

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

Device: - Exablate BBBD

BBB opening via Exablate Neuro Type 2 system to deliver carboplatin

Drug: - Carboplatin

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Status

Address

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5

Fondazione IRCCS Neurologico Carlo Besta, Milano, Italy

Status

Address

Fondazione IRCCS Neurologico Carlo Besta

Milano, , 20133

Yonsei University Medical Center, Seoul, Korea, Republic of

Status

Address

Yonsei University Medical Center

Seoul, , 120-752

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