Technical information

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All modules are not available in all markets.

Name and address of the manufacturer:

TheraPanacea

7 bis boulevard Bourdon
75004 Paris
France

Product name:

ART-Plan+™ is a medical device.

UDI: (01)03770019940020(8012)v.3.1.2(11)251216

The version of the software is 3.1.2 mentioned on its “About” module of the software.

Intended use:

ART-Plan+ is a software intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists and radiation oncologists. The software consists of different applications, each used for specific purposes at a different phase of radiation treatment planning.  

ART-Plan+ offers the following tools to aid in the workflow of radiotherapy treatment:  

  • Multi-modal visualization and rigid- and deformable registration of anatomical and functional images such as CT, MR, PET-CT,4D-CT and synthetic-CT generated from CBCT.  
  • Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user  
  • Automatic generation of contours for organs at risk, lymph nodes and tumors based on medical practices, on medical images such as CT and MR images  
  • Manual and semi-automatic creation, modification of contours for the regions of interest    
  • Generation of synthetic-CT from MR images for supported anatomies  
  • Generation of synthetic-CT from CBCT images for supported anatomies  
  • Dose computation on CT images for external beam irradiation with photon beams   
  • Assisted CBCT-based off-line adaptation decision-making for supported anatomies  
  • Automatic generation of radiotherapy treatment plan for supported prescriptions and anatomies that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval  

The device is intended to be used in a radiation therapy clinical setting, by trained professionals only.

Performance:

Quality:

The contours made in ART-Plan+ must be checked and validated by one or more authorized person(s). 

The user must circumvent on quality imagery. Lower quality volumes or volumes with artifacts (e.g., an implant) may result in misinterpretation of the patient’s anatomy by the software and thus produce low quality contours. Please check the quality of the images before loading them into the ART-Plan + solution. 

The quality of the contours may depend on the skills of the user and the quality of the imagery.

Processing time:

Please note that there may be variations in the processing time of ART-Plan + functions.

Under optimal conditions, the contouring of an anatomy with the automatic contouring tool can take between 2 and 3 minutes, depending on the number of structures detected.

If several actions are carried out simultaneously in ART-Plan, the processing time may increase.

The claimed time depends on the anatomy, the equipment used by the healthcare facility, the number of connected users and the type of actions already in progress. Additional time must be taken by the user to check and possibly modify the automatically generated contours.

Displayed values and precision 

Measurement  Unit  Precision 
Electronic Density Electronic Density (ED) 0,001
Hounsfied Unit Hounsfield Unit (HU) 0,1 

   A user manual is provided with the device.

   Precautions for use and contraindications:

The software is contraindicated outside the context of radiotherapy. The software may be used only for patients undergoing radiotherapy treatment.

  Warnings:

  • The user must take note of all the recommendations mentioned in this manual. TheraPanacea cannot be held responsible for any consequence linked to the non-observance of these recommendations.
  • A user account must be opened for users who have been trained by the manufacturer or by an ART-Plan + administrator in the organization using the software. Do not create a user account for a person who is not trained in the use of the software and/or does not have the necessary skills to use the software in the preparation of a radiotherapy treatment.
  • TheraPanacea cannot be held responsible for the creation of a user account by a person who is not trained in the use of the software and/or who does not have the necessary skills to use a software manipulated within the framework of the preparation of a radiotherapy treatment.
  • ART-Plan + is developed as a tool to assist in the preparation and follow-up of radiotherapy treatment and should not be used as a basis for diagnosis. Do not use ART-Plan + outside of the scope defined above.
  • If the deactivation of the solution is decided by the clinical practice facility, TheraPanacea cannot be held responsible for the deactivation of the solution and the consequences of the impossibility to use the solution
  • By deactivating the solution, the platform’s functions become inaccessible, and it is no longer possible to manipulate patient data. In this situation, the administrator of the solution should contact TheraPanacea to reactivate the solution.
  • Do not use the software after the period covered by the contract whether it is with the Cloud option or not. Therapanacea will not be able to maintain the installed version beyond the period defined in the contract.
  • ART-Plan + is a web-based solution. It may be necessary to refresh the page (F5 or Refresh button of the browser) in order to see the result of some tasks.
  • Contours generation, plan generation, synthetic-CT generation and dose computation may fail due to memory issues. In that case some time loss can be experienced while TheraPanacea resolve the issue.
  • In order to combat musculoskeletal and eye problems, the user should take regular breaks to limit fatigue leading to the above-mentioned problems.
  • When connecting to the platform with a phone or tablet screen, the user must select the “Computer Version” option of their communication device. The platform is best used for a screen size of 17 inches and above. It is not recommended to use ART-Plan + on a smaller device, as this may result in errors due to poor visualization or understanding of the interface.
  • Contours made in ART-Plan + must be verified and validated by one or more authorized person(s).
  • The automatic contouring function makes a proposal to the user. This proposal must be verified and validated by one or more users with the appropriate skills.
  • Non validated contours can be exported from ART-Plan + and downloaded into another soft- ware. In that case, make sure to validate those contours before using them for treatment planning.
  • We recommend hardly not to export non-validated contours.
  • The retention time of data stored is configurable on a case by case basis according to the client’s need.
  • The deletion of data is irreversible. We advise you to export the data to an external storage space before deleting them.
  • The server must be installed in a room with air conditioning and a high voltage outlet.
  • Do not install ART-Plan + on your own initiative, without going through TheraPanacea. The configuration and use of ART-Plan + in a non-contractual context could lead to loss of data and disruptions to the equipment and clinical treatment.
  • The server installation environment must be specified to TheraPanacea prior to the installation date. Non-compliant environment specifications could cause damage to the server.
  • Do not install other devices on the same server as the one used for the ART-Plan + software.
  • Some firewalls, if active, may block access to ART-PLAN +.
  • If one or more slices between the second and the second to last slice of a DICOM volume are missing, the volume will not be able to be loaded into the Annotate module. The user must verify that the total number of slices of the volume imported into ART-Plan + is the same as the total number of slices of the volume indicated in the hosting from which the DICOM was imported.
  • If a corrupted volume is imported into ART-Plan +, using it may cause the software to malfunc- tion or be misused by the user.
  • Do not import DICOMs that are corrupted or contain incorrect data. This could cause errors or malfunctions.
  • 2D DICOM images (e.g. scout images) can be imported on ART-Plan + but can’t be processed in Annotate and SmartPlan modules.
  • Importing data into ART-Plan + will not work if the required DICOM tags are not filled in and/or non-compatible information is indicated. Please refer to the DICOM Compliance document to know which DICOM tags are required and compatible with the solution. Note that wedges and accessories are not supported.
  • Importing data including incorrect information (sex, patient position, etc) could cause error or malfunction.
  • The user must contour on quality imagery. Lower quality volumes or volumes with artifacts (e.g., implant) may result in misinterpretation of the patient’s anatomy. Please check the quality of the images before loading them into the ART-Plan + software.
  • The quality of the images is variable. For instance, images with a poor resolution (e.g. CBCT), which are very noisy or which have been compressed with a lossy type, can lead to incorrect contours. The user must ensure that the quality of the primary image is good before starting the contouring step.
  • The automatic contouring (including external contour) function may generate inappropriate contours in the following cases:
    • When the volume used is an image taken of a child.
    • When the patient has a particular anatomy. This assessment is the responsibility of the user.
    • When the CT volume is that of a patient not positioned on his back at the time of acquisition.
    • If the value entered in the Patient Position tag (0018, 5100) is incorrect.
    • When the value entered in the Patient’s Sex Attribute tag (0010,0040) is empty or incorrect.
    • When the DICOM-CT contains an unusually high number of slices.
    • When the quality of the images used as input is not satisfying enough (including images with a poor resolution (e.g. CBCT), which are very noisy or which have been compressed with a lossy type).
    • When the volume is an MRI whose acquisition sequence is not compatible with the selected auto-contouring model.
    • When the patient is unusually positioned on the image (image not centered on the patient, head rotated on the side…).
    • When the structures present in the volume have localization specific to the patient position (e.g. arms down for humeral heads).
    • For organs that have been modified or removed by surgery (e.g. prostatectomy)
    • For symetrical structures for which there can be right/left inversions
  • The contouring function may generate contours in incorrect locations, for all whole structure or part of this structure (special attention must be paid to H&N vessels).
  • Performances of the autosegmentaion for H&N lymph nodes, lacrimal glands and pharyngeal constrictor muscles are higher on contrast-enhanced CT images rather than non contrast-enhanced CT images.
  • For pelvic and abdominal structures, the automatic contouring (including the external contour may generate inappropriate contours on CT images of patients below 60 years.
  • For H&N lymph nodes, lacrimal glands and pharyngeal constrictor muscles, the automatic contouring (including the external contour) may generate inappropriate contours on CT images:
    • acquired with other scanners than Sensation Opens from Siemens.
    • of patients below 50 years or above 79 years of age
  • External contour generation may not have satisfactory results when performed on anatomies not covered by automatic contouring:
    • Automatic contouring on CT images covers all anatomies.
    • Automatic contouring on MR images covers sequences and anatomies: Brain T1, Abdo TF, Pelvis T2, Pelvis TF.
  • Please create specific protocols to avoid unwilling structures (for instance: specific glioblastoma protocol without brainmets structures).
  • The dose engine must be validated by the user before use.
  • The structure mapping configuration influences plan generation. In case of ambiguous match- ing, the task fails.
  • The configuration of TPS and R&V affects plan generation. Only Monaco-Mosaiq, Eclipse- ARIA and Raystation are validated.
  • The ballistic configuration impacts plan generation. Only 1 or 2 beams can be utilized.
  • The definition of the patient support influences plan generation. The software automatically detects the treatment couch on structures having the type “support”or “fixation”. When those structures are not associated with custom ED values, values from CT shall be taken. In case there is no structure with type “support”or “fixation”, the software considers that there is no couch.
  • The RTSS used as input for SmartPlan must be checked for adequacy.
  • The user must validate the RTPlan by generating the RTDose using his/her TPS.
  • Bad image quality (artefacts, motion, uncommun high slice thickness, etc.) can lead to incor- rect synCT/dose. The user must check the quality of the synCT.
  • Results are based on a synCT image and contours that are not validated. Please review them before taking any action on the treatment course of the patient.
  • The quality of the CBCT is improved by AI and its field of view is augmented by duplicating the corresponding slices on the planning CT, after rigid registration. The elements generated on the augmented part (contours, dose) are therefore not reliable. Please pay attention to it.
  • The user must ensure that RTPlan and RTStruct sent for an AdaptBox analysis correspond to the ones used for patient treatment.
  • Flags are raised according to thresholds that are configured in protocols. Metrics values and thresholds are indicated in the report. Please check values before selecting the protocol for clinical use.
  • When there are several RTPlans linked to the same RTSS, the latest one is taken.

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