In the paper, the authors recommend creating a multi-disciplinary team of physicians to manage and treat the often young patients who present with these tumors. The comprehensive guidelines, which have been developed in conjunction with the clinical trial for the Philips Sonalleve focused ultrasound system, provide a framework for patient selection (diagnosis, imaging, preparation, and planning) and treatment. Final thoughts discuss avoiding complications and analyzing outcomes.
“Although the treatment is still under investigation, we are putting out these best practices guidelines to maximize outcomes, reduce variability across treatment sites, and encourage the addition of new sites,” said Michael J. Temple, MD. “We also make suggestions for a patient-centered outcomes registry and future comparative studies.”
Because it is noninvasive and radiation-free, focused ultrasound could replace the current standards of care: percutaneous radiofrequency (RF) or laser thermal ablation.
“This paper is really an expert consensus statement,” said Suzanne LeBlang, MD, the Foundation’s Chief Medical Officer. “The international authors from five institutions each bring considerable focused ultrasound experience, and we have combined that experience to outline the factors that should lead to the best technical success and excellent patient response.”
The Foundation funded the pilot study that contributed to the formation of these guidelines and has recently funded new research at UCSF for a comparative study with RF ablation that is likely to start next year. Stanford and possibly one other site will participate in that project.
A multicenter trial conducted from 2010 to 2012 on 29 patients who underwent FUS treatment for osteoid osteoma found a 90% clinical success rate, which is equivalent to CT-guided RF ablation. Additionally, when compared with RF ablation, the MR-guidance used with FUS provides superior thermal energy dose monitoring, and its non-invasiveness reduces the risk of infection without skeletal weakening. Focused ultrasound has also shown positive results in studies for other bone conditions, including palliation of pain from bone metastases, which is an FDA-approved treatment.
In North America, Sunnybrook Health Sciences Centre and SickKids together have treated seven patients, and a related trial at Children’s National Hospital in Washington, DC, has completed treatment for 9 patients. The University of Roma La Sapienza also has conducted a large, 60-patient clinical trial.