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Clinical trials

Sunnybrook has the most focused ultrasound clinical trials of any site in the world.

Sunnybrook is pioneering the application of focused ultrasound to new indications through active clinical trials including the following studies.

Alzheimer’s disease

Sunnybrook has launched the world’s first clinical trial to investigate the use of MRI-guided focused ultrasound to open the blood-brain barrier in people with Alzheimer’s disease. This phase 1 trial will evaluate the feasibility and safety of using focused ultrasound with an intravenous contrast agent to open the blood-brain barrier precisely and noninvasively in a small group of people with mild Alzheimer’s disease. This trial follows years of pioneering preclinical work at SRI under the leadership of senior scientist Dr. Kullervo Hynynen. Conducting the trial are neurosurgeon Dr. Nir Lipsman, the principal investigator; and neurologist Dr. Sandra Black, a world leader in dementia research. For more information, including eligibility criteria, visit the website: NCT02986932.

Brain cancer

In November 2015 Sunnybrook researchers made history by being the first in the world to breach the blood-brain barrier noninvasively using focused ultrasound. This work was part of a trial to test the safety of MRI-guided focused ultrasound paired with microbubbles to deliver a chemotherapy called doxorubicin directly into the brain tumour of a patient with brain cancer. The study, which is being led by Dr. Todd Mainprize, who heads neurosurgery at Sunnybrook, continues to recruit patients. For more information visit the website: NCT02343991.

View a video of Bonnie Hall, a patient who participated in the trial at Sunnybrook. To read more about this trial, visit the news and stories section.

Dr. Mainprize is also leading a clinical trial testing the safety and feasibility of MRI-guided focused ultrasound surgery for local treatment of progressive brain tumours in patients who have already received maximal surgical resection and radiation therapy. The study is recruiting patients. For more information visit the website: NCT01473485.

If you would like more information about participating in these trials please contact Allison Bethune, neurosurgical research coordinator, at 416-480-6100, ext. 4831.

Head and neck cancer

Sunnybrook researchers launched the world’s first clinical trial evaluating use of MRI-guided high-intensity focused ultrasound (HIFU) to treat head and neck cancer. The study is recruiting 10 patients with head and neck cancer to receive MRI-guided HIFU in addition to standard chemotherapy and radiation therapy. The aim is to assess the safety, toxicity and feasibility of focused ultrasound treatment that is given before palliative radiotherapy. The study will also look at changes in tumour tissue following focused ultrasound treatment.

Dr. Justin Lee, a radiation oncologist at Sunnybrook, is leading the study. If you would like more information about participating in the trial, please contact Dr. Lee or Merrylee McGuffin, clinical coordinator, at 416-480-6104.

Movement disorders

This trial is evaluating the safety and effectiveness of transcranial MRI-guided focused ultrasound in treating people with movement disorders that do not respond to medication. Conditions included are essential tremor, Parkinson’s disease, Wilson’s disease, Huntington’s disease, dystonia, tardive dyskinesia and orofacial dyskinesias. Dr. Michael Schwartz, a neurosurgeon at Sunnybrook, is leading the trial. For more information visit the website: NCT02252380.

Dr. Schwartz is also leading a trial to determine the effectiveness of the technique in treatment of dyskinesia (a movement disorder) that is a side effect of taking levodopa, a treatment for Parkinson’s disease. Participants will undergo MRI-guided focused ultrasound surgery to destroy a tiny part of the brain that is responsible for the dyskinesia. For more information visit the website: NCT02347254.

If you would like more information about participating in these trials, please contact Nadia Scantlebury, PhD, at 416-480-6100, ext. 4738.

Rectal cancer

This study is testing the feasibility and safety of using MRI-guided focused ultrasound in combination with radiation and chemotherapy to treat recurrent rectal cancer. The aim is to determine whether thermal treatment of cancer, via focused ultrasound, can be used safely with radiation and chemotherapy without increased negative side effects. The principal investigator is Dr. William Chu, a radiation oncologist at Sunnybrook’s Odette Cancer Centre and researcher at Sunnybrook Research Institute. This trial is recruiting participants. For more information visit the website: NCT02528175.

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