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Dr. Neal F. Kassell

Focused ultrasound's first North American pediatric patient

by Gus Iversen , Editor in Chief
On July 17th the Focused Ultrasound Foundation and the Hospital for Sick Children (SickKids) at Sunnybrook Health Sciences Center in Toronto, teamed up to treat a 16 year old male suffering from osteoid osteoma — a benign bone tumor in his leg. The patient became the first North American pediatric patient ever to receive high-intensity focused ultrasound (HIFU), and has recovered with no reported complications to date.

Osteoid osteoma occurs most commonly in males 10 to 35 years of age, but has been reported in patients as young as seven months. Despite its small size — about one centimeter — the tumor is known to cause extreme pain, and treatment itself has historically been a painful process with a drawn out recovery.

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Until the mid-90s, physicians would typically scrape the tumor from the bone or else remove the affected part of the bone entirely. Since then, radiofrequency or laser energy has been standard to burn the tumor away with the assistance of CT guidance.

Although comparably less invasive, that process may leave patients susceptible to radiation exposure, infection, burning of the surrounding tissue, and bone fractures resulting from the hole remaining after treatment.

HIFU therapy represents a virtually non-invasive alternative to the traditional courses of treatment. With the guidance of MR, HIFU utilizes sound waves to heat an area the size of a grain of rice and destroy the tumor.

It leaves the skin and surrounding bone entirely intact and, consequently, the risk of infection is greatly diminished. The use of MR rather than CT means the patient also avoids radiation exposure.

SickKids reports that the patient was discharged a few hours after the procedure and pain free within a few hours more.

"This is one of those pathfinder indications where it truly is superior to the best current therapy," Dr. Neal F. Kassell, the founder and chairman of the Focused Ultrasound Foundation, told DOTmed News. His foundation is currently funding numerous other clinical trials as well.

Although the procedure itself took 30 minutes, it required about three hours of preparation, which involved general anesthesia and precise placement of the patient on the table, which was equipped with a built-in, high-intensity focused ultrasound transducer manufactured by the Royal Philips Co. The MR enabled physicians to monitor the temperature induced by the ultrasound and ensure that there was no unexpected increase in heat in surrounding tissues.

The bone tumor treatment project is an initiative of the SickKids' Centre for Image-Guided Innovation and Therapeutic Intervention — a research program that brings together surgeons, radiologists, software developers and engineers to develop innovative technologies in robotic and minimally-invasive surgery.

"There will ultimately be twenty patients treated in this trial," said Kassell. "The first was the one that was reported, and that was one of 10 at the University of Toronto. By year end we hope to start in two other centers." Kassell intends to conduct those treatments in the U.S. and is currently seeking approval from the FDA.

HIFU therapy is available in pediatric and adult centers in Europe, and was first performed on patients with osteoid osteoma in Italy in 2010. In North America, the treatment is used on adult patients with uterine fibroids and bone metastases.

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