This page is applicable to the medical device sold in EU only. Not applicable in US or other 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)03770019940013(10)2.3.1(11)240724

The version of the software is 2.3.1 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, CBCT and pseudo-CT generated from CBCT
  • Display of fused and non-fused images to facilitate the comparison and delineation of image data by the user
  • Manual modification and semi-automatic generation of contours for the regions of interest
  • Automatic generation of contours for organs at risk and healthy lymph nodes, based on medical practices, on medical images such as CT and MR images
  • Generation of pseudo-CT from MR images for supported anatomies
  • Generation of pseudo-CT from CBCT images for supported anatomies
  • Dose computation on CT images for external beam irradiation with photon beams
  • Evaluation of volumetric changes and dose coverage changes on daily images in comparison with the planned dose to evaluate a treatment during the treatment course
  • Report standardized metrics to compare the delivered and planned doses that are based on the institution’s chosen standards to help identify the need for replanning

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

Performance:

Quality:

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

The quality of generated Pseudo-CT and doses may depend on the quality of the imagery.

Processing time:

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 accuracy

Measurement Unit Accuracy
Length Centimeter (cm) 0,01
Volume Cubic centimeter (cm3) 0,01
Volume Voxel 0
Electronic Density Electronic Density (ED) 0,0001
Hounsfied Unit Hounsfield Unit (HU) 0,01
Dose Gray (Gy) 0,01

   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 consequences related to the non-observance of these recommendations.
  • 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.
  • 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 data loss and disturbances on the equipment and the clinical treatment.
  • The server installation environment must be specified to TheraPanacea before the installation date. Non-compliant environment specifications could cause damages to the server.
  • Do not use the software after the period covered by the contract, whether with the Cloud option or not. Therapanacea will not be able to ensure the maintenance of the installed version beyond the period defined in the contract.
  • ART-Plan is a Web solution. It may be necessary to refresh the page (F5 or Refresh button of the browser) in order to visualize the result of some tasks.
  • If a corrupted volume is imported into ART-Plan, its visualization and use can lead to a malfunction of the software or a misuse by the user.
  • If one or more slices between the second and penultimate slice of a DICOM volume are missing, the volume cannot be loaded in the Annotate module. The user must verify that the total number of slices of the imported volume in ART-Plan is the same as the total number of slices of the volume indicated in the hosting from which the DICOM was imported.
  • Do not import 2D DICOM images (e.g. scout images) or DICOMs that are corrupted or contain incorrect data. This could cause errors or malfunctions.
  • A data format other than the one specified in this chapter will not be taken into account by the platform. To load DICOM files into ART-Plan from a local storage medium, the user must first compress them into a .zip file.
  • Import of data into ART-Plan will not work if required DICOM tags are not filled out and/or non supported information are indicated. Please refer to ART-Plan’s DICOM Conformance document to know required and supported DICOM tags by the solution.
  • A user account must be opened to users who have been trained by the manufacturer or by an ART-Plan administrator in the user structure of 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 a software manipulated in the preparation of a radiotherapy treatment.
  • The contours made in ART-Plan must be checked and validated by one or more authorized person(s). 
  • 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.
  • Please note that there may be variations in the processing time of ART-Plan functions.
  • Some firewalls, if active, may block access to ART-PLAN.
  • 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 a software manipulated in the preparation of a radiotherapy treatment.
  • In order to combat musculoskeletal and eye problems, the user should take regular breaks to limit the fatigue leading to the above-mentioned problems.
  • When connecting to the platform with a phone or tablet screen, the user should select the “Computer version” option of their communication device. The platform is optimally used for a screen size of 17 inches and more. It is not recommended to use the ART-Plan platform on a smaller device as it could lead to errors due to poor visualization or understanding of the interface.
  • Editing a category instantly changes the rights and access of all users in the category. The user modifying the category must verify that all impacted users have the rights and the appropriate access to their responsibilities, skills and experience.
  • Deleting a category results in the modification of each user account belonging to that category. They will be assigned the default category “User”. The user deleting a category must ensure that impacted users recover the rights and access that correspond to their responsibilities, skills and experience..
  • The user creating or modifying a user account must verify that the rights and access authorized by the assigned category match the skills and experience of that user.
  • Changing the category of a user account changes its rights and access. The user modifying the account must verify that the impacted user has the skills, responsibilities and experience required to belong to the selected category.
  • If the category of an account has been changed since deactivation, the user’s rights and access will also be changed. The user reactivating the account must verify that the new rights and accesses of the category assigned to the impacted user still correspond to his skills and experience. If this is not the case, he must assign a new category.
  • In order not to delay the work of users, users with the appropriate rights should regularly export and then delete patients to free up storage space.
  • These actions are irreversible. We advise you to export the data to an external storage space before deleting it.
  • Before deleting DICOMs from ART-Plan platform, the user must ensure that the patient’s DICOMs are stored on another medium.
  • If a deactivation request has been made by TheraPanacea, it is imperative that the clinical practice facility deactivate the ART-Plan solution. 
  • 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.
  • Please do not reactivate the solution until Therapanacea has informed you that the adverse event has been resolved.
  • The administrator must be fully aware of the consequences related to the management of the platform and the opening and definition of user accounts.
  • The quality and reliability of the above information depends on the imported data. Please verify data before importing them into ART-Plan.
  • In case of an error in the DICOM Frame Of Reference tag, imaging exams may be incorrectly grouped during data import. In case of inconsistency, please check the attributes of the DICOM file.
  • Verify the total number of slices of imported volumes. 
  • In case of re-import of a corrupted DICOM, the DICOM present in ART-Plan and re-imported will be replaced. The structures created and contoured in Annotate on the re-imported DICOM are not retained. 
  • Please verify that the type of import selected suits your needs.
  • The detection of similarities depends on the information contained in the DICOM tags.
  • When the user chooses to group data with different identifying information in one and the same patient, the identifying information is not changed in the DICOM files. As a result, the exported data will return to its original identifiers.
  • Before deleting DICOMs from ART-Plan platform, the user must ensure that the patient’s DICOMs and/or projects from the ART-Plan platform are stored on another medium.
  • The user must verify the identity of the patient and the name of the project before performing any action on the project.
  • The time it takes to load a project can affect the quality of the images viewed. The user must wait a few seconds before editing the project for optimal handling and visibility.
  • The primary image is used for patient positioning throughout the radiotherapy sessions. Contours and treatment planning are done on the primary image. When creating a project, please verify that the primary image corresponds to the positioning image. 
  • Only the following images can be used as primary image when creating a project:
    • CT image whose patient position is indicated as HFS, HFDL, HFDR, HFP, FFS, FFDL, FFDR or FFP in the Patient position tag (0018, 5100).
    • MR image An axial MRI whose value contained in the tag Image Patient Orientation (0020,0037) is (1,0,0).
  • Image quality is variable. The user must ensure the good quality of the primary image before starting the contouring step.
  • The choice of an appropriate primary image is the responsibility and appreciation of the user. 
  • The choice of an appropriate secondary image is the responsibility and appreciation of the user.
  • The user must check that the structures added with the “Structure list” function have not already been created by:
    • The “New Structure” function.
    • The launch of an automatic contouring.
    • Adding another list of structures.
  • If the structure added with the “Structure list” function has already been created, it will have the same name but contain an incremental number.
  • The quality of the simple brush depends on the tracing performed by the user.
  • The quality of the agile brush depends on the tracing done by the user and also on the quality of the image.
  • The quality of the single polygon depends on the plotting done by the user. 
  • The quality of the agile polygon depends on the plotting done by the user and also on the quality of the image. 
  • The quality of the interpolation depends on the plot made by the user and also on the quality of the image. Interpolated contours must be checked by the user. 
  • The automatic segmentation function makes a proposal to the user. This proposal must be checked and validated by one or more users with the appropriate skills.
  • 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. humeral heads), contours of these structures may be incorrect.
    • For organs that have been modified or removed by surgery (e.g. prostatectomy)
  • Contours generated on Pseudo-CT from MRI in the Annotate module can be incorrect.
  • When the user creates a structure, a standardized name is proposed. However, the user can modify this proposal to give the structure a name of his or her choice. In this situation, when the automatic contouring function is launched, the interface cannot inform the user of the presence of a duplicate between the automatically contoured structures and those already present in the regions of interest area. The user must check that there are no duplicate structures between those he or she has created and those generated by the automatic contouring function.
  • In order to suggest the most relevant structures to the user, a CT that does not include a chiasma but does include a liver, is not considered as Head and Neck case. In that case, no Head and Neck structures will be automatically segmented.
  • 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.
  • It is not recommended to use low-resolution input images such as CBCT for autosegmentation (including images with a poor resolution (e.g. CBCT), which are very noisy or which have been compressed with a lossy type), as it could lead to low quality contours.
  • Structure name and color settings defined for automatic contouring also apply in the case of automatic contouring of a secondary image.
  • Please note that there might be variations in the quality of contour transfers in the case of rigid fusion for CT-CT replanning. If you are not satisfied with the result, Therapanacea advises to perform a deformable fusion or to use the manual tools available to improve the quality of the contours.
  • Contours must be reviewed and validated by users with the appropriate expertise and skills.  
  • Non validated contours can be exported from ART-Plan and downloaded into another software. In that case, make sure to validate those contours before using them for treatment planning.
  • We hardly recommend not to export non-validated contours.
  • Depending on the type of MR-RT, the results may differ.
  • Bad image quality (artefacts, motion, uncommon high slice thickness, etc.) can lead to incorrect Pseudo-CT.
  • Please be careful to choose the correct pseudo-CT model associated with the primary MR image.
  • Although ART-Plan does not offer dose calculation tools, manual customization of HU values may affect future dose calculations computed on other devices based on modified CT. Please review every HU modification before exporting the CT.
  • Please check the quality of the pseudo-CT before validating it. 
  • Please check the quality of contours from the automatic delineation, before using it to validate the pseudo-CT.
  • Particular attention is required when entering data in the tables “HU reference values” and “calibration curve”. Indeed, these values have an influence on the generation and evaluation of the Pseudo-CT.
  • Warped images (generated from a validated fusion) and other generated images in ART-Plan (projections, Pseudo-CT) can be exported from ART-Plan and downloaded into another software. In that case, please make sure to not confuse these images with original images. For this purpose, you can use the following DICOM tags:
    • Series Description (0008,103e): contains  “fusion” or the name of a projection or “Pseudo-CT”,
    • Image type (0008,0008) : “Derived”,
  • The automatic batch contouring functions(including external contour) can generate inappropriate contours in the following cases:
    • When the image used as the primary image is an image taken of a child.
    • When the patient has a particular anatomy. This assessment is the responsibility of the user.
    • When the primary image is that of a patient not positioned on his back during acquisition.
    • When the value entered in the Patient position tag (0018, 5100) is wrong.
    • The automatic contouring function to be applied depends on the user’s selection.
  • Please check Patient’s Sex Attribute tag (001,0040) before sending an image to batch to verify that it is not empty and correct.
  • The automatic contouring function makes a proposal to the user. This proposal must be checked and validated by one or more users with the appropriate skills.
  • The DICOM Series description, Study description, Protocol name and Bodypart examined tags must be checked before sending an image in batch. Facility centers using this configuration should inform users of the processes to be implemented according to their protocol.
  • When an automatic contouring is launched on a whole CT acquired below the chiasma (chiasma does not present on the image) and in which the liver is present, the ORL structures are not contoured because it is considered that it is not an ORL case.
  • Before sending an image in Batch, please check the content of the DICOM tag to enable or disable keyword dependent templates. Facility centers using this configuration should inform users of the processes to be implemented according to their protocol.
  • Fusions must be verified before they are used in patients’ treatments.
  • All fusions initiated through manual or automatic methods may be modified and must be verified and approved by the users before use in a clinical context.
  • The maximum of the deformation scale of the deformation grid tool is 2 cm. All deformation values greater than 2 cm will be displayed with the same color (red) on the screen. For the exact deformation value, please refer to the information in yellow in the lower left corner of the screen.
  • This modification option causes the previously established fusion to be deleted.
  • In the case of a group of secondary images, validating a fusion will validate each warped image in the group. Please verify each warped image before validating the fusion.
  • In the case of a group of linked sources, deleting a fusion will delete each warped image in the group. Please make sure that no warped images are used.
  • If a corrupted volume is sent to the ART-Plan cloud option, its use may result in software malfunction or user misuse.
  • Do not send 2D DICOM images, corrupted DICOME or DICOMs containing erroneous data to the ART-Plan cloud option. This may cause errors or malfunctions.
  • A data format other than the one specified in this chapter will not be taken into account by the ART-Plan cloud system.
  • Importing data into the ART-Plan cloud option 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 for the required DICOM tags that are compatible with the solution.
  • ART-Plan Connect is an application to be installed on a local machine, TheraPanacea does not guarantee the installation and the correct functioning of ART-Plan Connect on other types of machines.
  • The ART-Plan Connect application can only be installed and used on a compatible operating system.
  • It is recommended that the user install appropriate anti-virus software on the machine on which ART-Plan Connect is installed to provide sufficient protection for the proper functioning of the application.
  • Incorrectly filling in the Excel file may result in treatment errors on the patient. TheraPanacea cannot be held responsible for a wrong filling.
  • The user must carefully check the parameters filled in for the output DICOM applications. When using the cloud system, the data will be automatically sent out of the cloud system to the filled in applications.
  • Therapanacea recommends reviewing the automatically generated contours with the cloud system and automatically exported to the output DICOM applications.
  • By default, data are deleted after 6 months. To change this duration, please contact TheraPanacea.
  • The AdaptBox module has been designed for the analysis of male pelvic cases. Please do not use it for other anatomy.
  • The choice of a suitable CBCT is the responsibility and judgment of the user. The CBCT must be chosen in order to be able to compare it to the associated Planning-CT.
  • Only the following images can be used as a secondary image when launching the AdaptBox process:
    • CT whose patient position is indicated as HFS, HFDL, HFDR, HFP, FFS, FFDL, FFDR or FFP, in the tag Patient position (0018, 5100).
    • The image must be different from the one chosen as the primary image
  • If the selected CBCT is not linked via a DICOM REG to the Planning-CT or that the Frame Of Reference tag of the CBCT and the Planning-CT are not the same, the dose calculation will not be possible because the registration of the CBCT on the Planning-CT cannot be done.
  • When selecting the secondary image, the user must be careful not to select the same CBCT twice and therefore assign it different fraction numbers.
  • The Pseudo-CTs generated within the AdaptBox module only aims at detecting a need for replanning and should not be used for treatment planning.
  • 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.
  • Please check the quality of the contours of the automatic delineation, before using it to validate the Pseudo-CT.
  • Results may vary depending on the type of scanner.
  • A bad quality image (artefacts, blur, etc.) may lead to an erroneous dose computation.
  • Please ensure that the RTPlan selected to calculate the dose matches the one used to treat the patient. 
  • Before using the dose calculation on a clinical case, please validate that its performance level corresponds to what is expected.Special care should be taken on plans with small field sizes (<2cmx2cm), limited accuracy has been found.
  • Before importing an RTPlan on ART-Plan, please ensure that it meets the provided DICOM Conformance Statement.
  • Wedges and accessories are not supported by the dose calculation.
  • The loading time of a project can affect the quality of the images viewed. The user must wait a few seconds before editing the project for optimal handling and visibility.
  • The choice of volume and dose metrics is entirely left to the discretion of the user.
  • If the user decides to modify an already existing template, he must take into account that the results obtained with the fractions calculated previously with this same template will be updated with the modification of the template.
  • An indication of replanning or non-replanning must be checked and validated by the user using the tools made available and his know-how. 
  • A fusion done with an Elekta CBCT with an automatic initialization may give incorrect results. In that case, it is recommended to initialize manually the fusion with the alignment tool (see 6.1.1.2), before launching the fusion
  • The fusion used for automatic contouring function on secondary image may be incorrect when the secondary volume and the primary volume have significantly different cut thicknesses.
  • The Pseudo-CTs model within the AdaptBox module has to be launched only on male Pelvis anatomy. Other anatomy/gender could lead to incorrect Pseudo-CT. 
  • The Pseudo-CTs model within the AdaptBox module has to be launched only on Elekta and Varian CBCT. Other CBCT could lead to incorrect Pseudo-CT.
  • It is not recommended to use Pseudo-CT (from CBCT and MR images)  generated in ART-Plan for autosegmentation in the Annotate module as it could lead to low quality contours.
  • 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 or above 79 years of age
  • Performances of the autosegmentation 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.