DOSIsoft Receives FDA 510(k) Clearance for Planet Onco Dose Software

June 20, 2019 — DOSIsoft announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Planet Onco Dose software for its oncology and yttrium-90 (Y-90) microsphere SIRT 3-D dosimetry components.

Planet Onco Dose is a comprehensive software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.

Planet Onco Dose is a modular software suite composed of two main elements:

• Planet Onco: The oncology module with core system features, comprehensive reviewing of multimodal molecular image series (computed tomography, magnetic resonance imaging, positron emission tomography, single photon emission computed tomography), fusion and registration, automatic and semi-automatic contouring of regions of interest, tumor segmentation, quantification, tumoral activity monitoring and therapy response assessment; and

• Planet Dose: The dosimetry module including 3-D personalized voxel-based internal dosimetry computation dedicated to molecular radiotherapy (MRT)

Planet Onco provides advanced tools to display, co-register (including deformable registration), compute standardized uptake value and import/export results (contours and quantification results) to/from treatment planning systems and picture archiving and communication system (PACS) devices for assessment, treatment planning and response of patients undergoing a course of oncology treatments.

DOSIsoft has transferred its external radiation therapy advanced software technology to nuclear medicine and molecular radiotherapy. CE marked since March 2016, Planet Onco Dose is the first fully integrated imaging and personalized 3-D dosimetry platform for radionuclide-based therapies, according to the company.

Planet Onco Dose is intended to assist the user in the diagnosis, quantification and verification of radiation doses received by tissues as a result of administering permanent Y90 microsphere implants, as well as in therapy response follow-up.

The software provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 microspheres:

• Three-dimensional (3-D) liver-lung shunt assessment;

• Voxel-based dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series;

• Dose computation models: Local Deposition Method and Voxel S Value Dose Kernel Convolution approach;

• Analysis down to any liver sub region: healthy liver, lobes, tumors, toxicity regions;

• Advanced and interactive dosimetry quantification (profile, dose-volume histograms, statistics, etc.);

• Ability to scale to known activity; and

• Compatible with PET images acquired with another radioisotope (correction of branching ratio and decay parameters).

For more information: www.dosisoft.com