Karun Sharma, MD, PhD, Director of Interventional Radiology, and colleagues at Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Health System in Washington, DC, have completed their clinical trial to treat benign but painful bone tumors (osteoid osteoma) in children. They have published the results, which demonstrated safety and efficacy for focused ultrasound, and then compared the results to a historical control group of children treated with radiofrequency ablation (RFA) in The Journal of Pediatrics. Children's National was the first children's hospital in the US to conduct a clinical trial using focused ultrasound to treat pediatric osteoid osteoma with the Philips V2 Sonalleve system.
The clinical trial compared nine patients, ages 6 to 16, who received focused ultrasound treatment with historical data for nine patients, ages 6 to 10, who previously underwent CT-guided RFA. The results found focused ultrasound to be a feasible and safe treatment method that demonstrated clinical improvement similar to RFA. Other advantages of FUS over RFA include reduced risk of infection, no exposure to ionizing radiation, no skin incisions, and decreased risk of fracture. FUS was also faster than RFA, with an estimated completion time of 90 minutes or less.
The focused ultrasound program at Children's National is part of the Image-Guided Noninvasive Therapeutic Energy (IGNITE) consortium led by Peter Kim, MD, PhD. The collaborative initiative aims to develop technology for minimally invasive and noninvasive surgery and combination therapy approaches that improve quality of life and outcome for pediatric patients. This study, said Dr. Kim, "is a perfect example of our mission in the Sheikh Zayed Institute to make pediatric surgery more precise, less invasive, and pain-free." The Foundation staff have enthusiastically participated in previous IGNITE workshops and events.
Children's National is currently studying focused ultrasound in two other pediatric solid tumor clinical trials for desmoid tumors and sarcomas.
Up next for pediatric osteoid osteoma is a pivotal clinical trial beginning at the University of California, San Francisco, and Stanford University. This study is the next step for regulatory approval in the US and will use the Insightec Exablate system, potentially paving the way for FDA clearance of two different focused ultrasound systems for this indication.