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Oncology trials

A Study to Evaluate the Safety and Feasibility of Blood-Brain Barrier Disruption Using MRI-Guided Focused Ultrasound in the Treatment of Her2-Positive Breast Cancer Brain Metastases

It’s estimated that 30% of patients with HER2-positive metastatic breast cancer, also develop of brain tumors. Delivering chemotherapy drugs to the brain has been a challenge due to the blood-brain barrier, which normally restricts substances from the bloodstream into the brain to protect it.

In recent years, Sunnybrook scientists have made history using focused ultrasound to non-invasively open the blood-brain barrier and deliver chemotherapy more effectively, into the brain tumours of patients.

This study is investigating the safety and feasibility of blood-brain carrier disruption using MRI-Guided Focused Ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the amount of chemotherapy drug delivered to brain tumours in the treatment of patients with HER2-positive breast cancer brain metastases.

This study will enroll up to 10 patients to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.

The follow-up visits are scheduled at 1 week, 4 and 12 weeks after the treatment and safety will be evaluated via clinical and neurological assessments and MR imaging throughout various time points.

For more information or to inquire about eligibility for the trial, please contact Maheleth Llinas at

Assessment of the Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy

This study will investigate the safety, feasibility, and efficacy of opening the blood-brain barrier along the periphery of tumor resection cavity using ExAblate® Neuro System, a focused ultrasound device, and chemotherapy treatment in patients with high grade Glioblastoma (GBM).

After undergoing surgical resection or biopsy, patients with GBM typically receive chemo-radiotherapy and temozolomide(TMZ), an oral chemotherapy drug, for 6 weeks. In this study, , blood brain barrier disruption will be applied on day 1 of each chemotherapy cycle for up to 6 cycles.

Up to 10 patients will be recruited for the treatment arm and 10 additional ones for the control arm. The latter will be patients who are eligible for the maintenance phase of TMZ but who do not wish to consent to BBB disruption component of the study.

As follow-up, those undergoing the focused ultrasound procedure, in addition to the 6 treatment visits, will return to hospital for study-related follow-up visits at 6 (at the end of the 6th and last treatment cycle) and 12 months. Those in the study control group will return for study related follow up visits at the end of the 28-day treatment cycles at 3, 6 and 12 months.

At all scheduled study follow-up visits, all participants will undergo physical and neurological examination, MR imaging with contrast and a check for side effects from the procedure or chemotherapy.

For more information or to inquire about eligibility for the trial, please contact Maheleth Llinas at

A Safety and Feasibility Study toEvaluateBlood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound with Intravenous Ultrasound Contrast Agents and Chemotherapy in the Patient with Diffuse Intrinsic Pontine Gliomas

Diffuse intrinsic pontine glioma (DIPG) is a deadly paediatric brain cancer, which accounts for 10-20% of all paediatric brain tumors.

This study will evaluate the safety of focal BBB disruption using the ExAblate® Neuro System and Definity® ultrasound contrast in up to 9 pediatric patients with DIPG. This study will be conducted in collaboration with Sunnybrook Hospital and the Hospital for Sick Children.

We will aim to identify the optimal sonication volume by titrating the sonication volume by groups (i.e., 3 x 3 study design). After the first group receives a focal sonication, and no serious adverse effects are found, the treatment will expand to another group and incorporate half of the tumor volume. A third group will progress to involve full tumor volume sonication, if no serious adverse events are encountered.

The procedure will be coordinated with the radiation and medical oncology colleagues at the Hospital for Sick Children in order to provide the necessary care after treatment. This includes radiation and chemotherapy regimen keeping with standards offered at the Hospital for Sick Children for patients with DIPG.

The follow-up visits are scheduled at 1 week, 1 month, and 3 months after the treatment. During each visit, the subject is evaluated for safety by physical and neurological examination, and MR imaging with contrast (except at Week 1).

For more information or to inquire about eligibility for the trial, please contact Maheleth Llinas at