Clinical Trial Combining Focused Ultrasound and Chemotherapy for Brain Metastases Begins in Toronto


The first patients have been treated in a clinical trial that aims to use focused ultrasound to enhance the effectiveness of chemotherapy drugs in those with Her2+ breast cancer that has metastasized to the brain.

Led by Nir Lipsman, MD, PhD, neurosurgeon and director of the Harquail Centre for Neuromodulation at Sunnybrook Health Sciences Centre in Toronto, the trial will assess the safety and feasibility of using Insightec’s Exablate Neuro focused ultrasound device to temporarily disrupt the blood-brain barrier (BBB) in these patients.

The BBB is a protective layer of tightly joined cells that lines the blood vessels in the brain and prevents harmful substances, such as toxins and infectious agents, from diffusing into the surrounding brain tissue. However, it can also prevent therapeutic agents – like chemotherapy – from getting into the brain. In this trial, patients will be administered Herceptin, a common chemotherapy drug, and researchers will determine if opening the BBB allows the drug into the brain in higher concentrations than is normally observed.

To date, three patients have been treated in the trial. In all, the Sunnybrook team plans to recruit up to 10 patients, and researchers also hope to expand the current single-treatment protocol to up to six treatments with a combination of chemotherapies.

The Focused Ultrasound Foundation is proud to fund this important trial.

Kathryn MRI Sunnybrook Herceptin 2 16x9Meet Kathryn: The First Patient

At 33, Kathryn was posed to launch her law career when she was suddenly diagnosed with an aggressive form of breast cancer. Despite efforts to control it, the disease eventually spread to her brain. She was the first patient treated in this landmark trial.

Read Kathryn’s Story >

Nir Lipsman 16x9Learn More about the Trial

The trial’s principle investigator, Nir Lipsman, MD, answers questions about the trial and how they hope to expand it in the future.

Read the Q&A with Dr. Lipsman >