FDA grants 510(k) clearance to software suite for molecular imaging and molecular radiotherapy dosimetry

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imagingThe US Food and Drug Administration (FDA) has granted 510(k) clearance to the company DOSIsoft to market its Planet Onco Dose software, for its oncology and Yttrium-90 (Y90) microsphere selective internal radiation therapy (SIRT) 3D dosimetry components.

According to a company press release, 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.

It is a modular software suite comprised of two main elements: an oncology module (Planet Onco) and a dosimetry module (Planet Dose). The former, the oncology module, has the core system features: comprehensive reviewing of multimodal molecular image series (CT, MRI, PET, SPECT), fusion and registration, automatic and semi-automatic contouring of regions of interest, tumour segmentation, quantification, tumoural activity monitoring, and therapy response assessment. The dosimetry module includes 3D personalised voxel-based internal dosimetry computation dedicated to molecular radiotherapy (MRT).

CE marked since March 2016, Planet Onco Dose is the first fully integrated imaging and personalised 3D dosimetry platform for radionuclide-based therapies, the company states.

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.

Planet Onco Dose 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 Y90 microspheres:

  • 3D liver-lung shunt assessment
  • Voxel-based dosimetry based on Y90-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)
  • Ability to scale to known activity
  • Compatible with PET images acquired with another radioisotope (correction of branching ratio and decay parameters)

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