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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

About 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 large substances from the bloodstream into the brain..

This study is investigating the safety and feasibility of blood-brain barrier opening in conjunction with an intravenous ultrasound contrast agent to increase the amount of antibody therapy 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 safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.

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

Status: Enrolling

For more information or to inquire about eligibility for the trial, please email harquailcentre@sunnybrook.ca. Please indicate in the subject line your diagnosis and which study you are inquiring about.

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 is investigating the safety, feasibility, and efficacy of opening the blood-brain barrier along the periphery of tumor resection cavity using focused ultrasound,, and chemotherapy treatment in patients with high grade Glioblastoma (GBM).

After undergoing surgical resection or biopsy, and a combination of radiation with chemotherapy patients with GBM typically receive oral chemotherapy temozolomide (TMZ), for six monthly maintenance cycles. In this study, blood brain barrier disruption will be applied on day 1 of each chemotherapy cycle in up to 20 patients.

Follow-ups, include imaging and clinical assessments up to 12 months.

Status: Enrolling

For more information or to inquire about eligibility for the trial, please email harquailcentre@sunnybrook.ca. Please indicate in the subject line your diagnosis and which study you are inquiring about.

Exablate Blood-Brain Barrier Disruption (BBBD) with Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy

Glioblastoma recurs in nearly all subjects and no clear standard has emerged showing improved outcomes. This safety and feasibility study is using focused ultrasound to temporarily open the BBB to deliver Carboplatin chemotherapy in up to 6 cycles approximately 10 rGBM subjects. Progression-free survival (PFS) and OS data will be data collected.

We will approach patients who have radiographic progression after first line therapy that included concurrent radiation and chemotherapy. Subsequent treatment cycles may include the original area, and any other areas of adjacent infiltrating tumor consistent with high grade glioma. Post treatment, if necessary, the patient will stay overnight for observation and will be discharged the following day. Subjects will return for study follow-up up to 18 months following last treatment cycle.

Status: Expected 2022

For more information or to inquire about eligibility for the trial, please email harquailcentre@sunnybrook.ca. Please indicate in the subject line your diagnosis and which study you are inquiring about.

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 terminal paediatric brain cancer, which accounts for 10-20% of all paediatric brain tumors.

This study will evaluate the safety of up to 3 focal BBB opening sessions using focused ultrasound in up to 10 pediatric patients with DIPG. This study will be conducted in collaboration with the Hospital for Sick Children.

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 up to 3 months after the last focused ultrasound treatment. During each visit, patients will be evaluated for safety by physical and neurological examination, and MR imaging.

Status: Expected 2022

For more information or to inquire about eligibility for the trial, please email harquailcentre@sunnybrook.ca. Please indicate in the subject line your diagnosis and which study you are inquiring about.