Guidelines

The Focused Ultrasound Foundation has developed a collection of guidelines in collaboration with researchers in relevant fields along with our Cancer Immunotherapy Scientific Advisory Board.

In order to ensure consensus on these recommendations, and to account for newly available data and technologies, the guidelines will be reviewed on an ongoing basis. These documents also remain open for comments, and you are invited to submit your suggestions via email.

We encourage researchers to consult these guidelines when planning their focused ultrasound preclinical and clinical studies and apply them if possible. The Foundation strongly recommends that these guidelines be used in studies that we are evaluating for funding support.

Guidelines for Immune Analysis During Focused Ultrasound Research

Local focused ultrasound treatment of neoplastic lesions that induces or enhances a systemic anticancer immune response could provide major therapeutic benefits to patients with cancer.

Monitoring the characteristics and temporal evolution of the immune response will provide key information needed to maximize the effectiveness of focused ultrasound treatment. This information is necessary to optimize focused ultrasound treatment parameters while further increasing the likelihood of therapeutic success through combination with immunotherapeutic agents or chemotherapies known to have immunostimulatory effects.

The guidelines, both for preclinical and clinical studies, include suggestions for analysis routes and assays. We emphasize the need to run a few very pointed assays/analyses first, before storing the remaining samples for later analysis.

See “Guidelines for Immune Analysis Following FUS Treatment – Preclinical”
See “Guidelines for Immune Analysis Following FUS Treatment – Clinical”

Guidelines for Focused Ultrasound Treatment Reporting

The community has identified the need for a set of guidelines to establish key parameters to report and the associated measurement methodologies to use for focused ultrasound research. The guidelines outlined in this document aim to fulfill three main objectives:

To ensure consistency in the reporting of focused ultrasound treatment parameters, to allow 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, necessary for (1) cross-comparison of studies, (2) validation of therapeutic bioeffects
To provide guidelines for testing and calibration of the focused ultrasound systems and protocols

The guidelines propose overall recommendations for important parameters to report; detailed methodologies for measuring/simulating focused ultrasound system and field parameters, detailed methodologies to assess bioeffects, DQA procedures for focused ultrasound equipment, and links to relevant standards and references.

See “Guidelines for Treatment Reporting”

The Foundation advocates for open data practices and has created and will maintain a data repository. The creation and maintenance of projects in the collection will come at no cost for the investigators.

Our objective is to create an ecosystem of focused ultrasound data providing researchers with the opportunity to access the source data in order to replicate, re-analyze, or support the development of their own projects or protocols.

These data will include source data, methodology, descriptions of experimental systems and their characterization, and details of any software used to process the results.

These guidelines provide information about data to be included, where the data should be stored, and how data should be presented.

See “Guidelines for Data Sharing”