Focused ultrasound is a versatile technology that can interact with tissue in diverse ways to produce more than 18 different bioeffects. This versatility makes focused ultrasound a potential treatment for more than 130 medical conditions. However, without clear standardization of treatment reporting and methodologies for measuring and describing key parameters for preclinical and clinical investigations, these diverse “modes” of focused ultrasound can also present a unique barrier to widespread clinical translation.
A general challenge often discussed at the Foundation’s workshops and symposia is the difficulty comparing treatment parameters from one focused ultrasound device to another. Furthermore, with no consistent standards for measurements and reporting, it can be impossible to reproduce results across multiple laboratories. The consensus view has identified the need for a set of guidelines to recommend key parameters to report and measurement methodologies to use; the aim would be for the entire focused ultrasound community to begin using these guidelines for future research.
In recent months, the Focused Ultrasound Foundation has drafted guidelines, with the input of several focused ultrasound scientific and technical experts, and we are pleased to invite public comment on a draft of this document.
The guidelines outlined in this document aim to fulfill three main objectives:
- To ensure consistency in the reporting of focused ultrasound treatment parameters, which will enable cross-comparison of studies performed by different groups and/or with different systems;
- To provide guidelines for assessing and reporting bioeffects associated with different focused ultrasound treatment regimens, which is necessary for cross-comparison of studies and validation of therapeutic bioeffects;
- To provide guidelines for testing focused ultrasound systems and protocols.
The guidelines are divided into five sections:
- Overall recommendations for important parameters to report;
- Detailed methodologies for measuring/simulating focused ultrasound system and field parameters;
- Detailed methodologies to assess bioeffects;
- Daily Quality Assurance (DQA) procedures for FUS equipment; and
- Relevant standards and references.
The Foundation is seeking public comments on these guidelines to ensure that they are comprehensive and address challenges faced by the community. The public comment period is open until July 15, 2020.
Your feedback is essential so please comment by July 15.