Trial document





This trial has been registered retrospectively.
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  DRKS00011407

Trial Description

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Title

Prospective observation study in the positioning of patients during radiotherapy by applying an optical surface scanner (Catalyst ™ system)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In modern radiation therapy, the irradiation dose can be precisely inserted into the planned target area. However, this presupposes a precise positioning of the patients on the irradiation device. In the course of radiotherapy, the storage is therefore regularly checked by checking and corrected in case of deviations. The standard methods for storage control are verification images (X-ray images) or computer tomography images on the irradiation device.

In the clinical study, a method of surface scanning is additionally applied and compared with the above mentioned reference methods. In this method, the surface is scanned by a light beam with a CE-certified C & RAD Catalyst ™ surface scanner to determine the spatial positioning. The system is already routinely used for the storage and monitoring of irradiation in our clinic. Surface scanning increases the time required by approximately half a minute for each therapy session.

Within the scope of the study, storage values ​​are collected in millimeters and subsequently evaluated anonymously. Results of the study can help to further improve the precision of radiotherapeutic treatment of patients in the future, and to replace the classic methods for inventory control.

The target area and irradiation dose for irradiation are determined independently of the participation in the study and correspond to the requirements of international and national guidelines, as well as clinical internal standards. The study does not expect any advantages, disadvantages, risks or burdens.

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Brief Summary in Scientific Language

The current procedure for the irradiation of patients in radiotherapy involves the initial implementation of a planning computed tomography (CT) for the generation of the irradiation plan. In order to ensure a precise and reproducible storage of the patient over the entire series of therapies, the patient is already stored in the planning CT with the aid of various storage aids (head cover with mask, arm supports, vacuum pads, etc.). In order to be able to precisely reproduce these complex exposures during the following workplace irradiation, water-resistant skin markings are placed on the patient surface, after which the patient is newly stored before each irradiation session. The patient is placed on the skin markings using a room laser system.
At the first irradiation date, a Cone-Beam CT (CBCT) or orthogonal verification recordings are made using iViewGT ™ for storage control and the irradiation plan is subsequently radiated. A CBCT is manufactured with an X-ray source attached directly to the irradiation device and an opposing detector. By rotating the gantry during recording and subsequent reconstruction of the individual images, CT-like images can be created. During the further irradiation sessions, a CBCT is re-established daily to weekly to control and possibly correct the patient's storage. Alternatively verification verifi- cations can be made. These are created via an electronic portal imaging system. In order to check the exact localization of the therapeutic fields, a very small dose of x-ray images is produced with the therapeutic beam. These radiographs ("verifications") are compared with the DRRs (digital reconstructed X - ray images from the irradiation planning system) and, if necessary, the patient position is corrected by moving the table and new skin marks are placed on the skin surface of the patient Application of ionizing x-ray radiation, which is applied to the patient in addition to the therapeutic radiation dose, and it is thus of particular clinical relevance to evaluate alternative applications of patient storage methods without ionizing radiation.

In recent years, optical surface scanners have been developed by various manufacturers, which are currently commercially available and CE-certified. LMU's Clinic for Radiation Therapy has a Catalyst ™ -HD system from C-RAD AB, Sweden at Campus Großhadern, as well as at the Campus Innenstadt. This system is an alternative to conventional patient positioning and is performed without additional radiation exposure to the patient.

Catalyst ™ -HD is a system for scanning the surface of patients by means of a light pattern to compare it with a reference image, either from the PlanCT data set or a reference image directly taken with the scanner. This allows correct patient positioning and verification, which is performed completely without ionizing radiation.
Three Catalyst scanners are available on the irradiation unit, which are attached at an angle of 120 ° to each other. The arrangement of the three scanners ensures a complete scanning of the body surface even during rotations of the irradiation head or the table. Each scanner is equipped with a CCD camera for recording the surface and an LED projector for projection of the pick-up pattern. The main camera is also a back projection of the necessary corrections on the patient surface. The scanning range is 80x140x140 cm with a measuring accuracy of 1 mm.
The Catalyst ™ system offers the possibility to present anatomical areas of patients who are not yet in the right storage position. The advantage over the 3-point laser placement over the skin markers is the scanning of the entire patient surface by the Catalyst ™ system. Both translations and rotations are indicated and necessary corrections, absolute as well as relative to the table position, are displayed in the room by means of numerical values. In addition, regions to be corrected on the patient surface are highlighted in color, so that the storage can be adapted accordingly.
Furthermore, the Catalyst ™ system monitors all patient movements during the irradiation session. The live image last recorded during storage is used as a reference image and continuously compared with the live images. The differences can be used to reverse a possible movement of the patients.

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Organizational Data

  •   DRKS00011407
  •   2017/01/12
  •   [---]*
  •   yes
  •   Approved
  •   352-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   Malignant neoplasms of multiple entities
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   As a storage control, the daily storage on water-resistant skin markers with the help of a space laser system as well as a daily to weekly cone beam CT (CBCT) (X-ray source and detector on the irradiation device with gantry rotation allows CT-like images) or orthogonal verification images using iViewGT ™ (low-dose therapeutic beam to create x-ray images) with subsequent reference image comparison and eventual bearing alignment.

    The CBCT and the verification images are based on the application of ionizing x-ray radiation, which is applied to the patient in addition to the therapeutic radiation dose. Therefore, it is of particular clinical relevance to evaluate alternative applications of patient storage methods without ionizing radiation.

    In recent years, optical surface scanners have been developed by various manufacturers, which are currently commercially available and CE-certified. LMU's Clinic for Radiation Therapy has a Catalyst ™ -HD system from C-RAD AB, Sweden at Campus Großhadern, as well as at the Campus Innenstadt. This system is an alternative to conventional patient positioning and is performed without additional radiation exposure to the patient.

    Catalyst ™ -HD is a system for scanning the surface of patients by means of a light pattern to compare it with a reference image, either from the PlanCT data set or a reference image directly taken with the scanner. This allows correct patient positioning and verification, which is performed completely without ionizing radiation.
    Three Catalyst scanners are available on the irradiation unit, which are attached at an angle of 120 ° to each other. The arrangement of the three scanners ensures a complete scanning of the body surface even during rotations of the irradiation head or the table. Each scanner is equipped with a CCD camera for recording the surface and an LED projector for projection of the pick-up pattern. The main camera is also a back projection of the necessary corrections on the patient surface. The scanning range is 80x140x140 cm with a measuring accuracy of 1 mm.
    The Catalyst ™ system provides the ability to present anatomical areas of patients who are not yet in the right storage position. The advantage over the 3-point laser placement over the skin markers is the scanning of the entire patient surface by the Catalyst ™ system. Both translations and rotations are indicated and necessary corrections, absolute as well as relative to the table position, are displayed in the room by means of numerical values. In addition, regions to be corrected on the patient surface are highlighted in color, so that the storage can be adapted accordingly.
    Furthermore, the Catalyst ™ system monitors all patient movements during the irradiation session. The live image last recorded during storage is used as a reference image and continuously compared with the live images. The differences can be used to reverse a possible movement of the patients.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of the present study is to verify to what extent the use of surface scanning by the CE certified Catalyst ™ system provides equally precise storage control parameters as generated by reference methods. With an optimum storage precision, the frequency of the storage control could be reduced by means of additional ionizing radiation.

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Secondary Outcome

Furthermore, the extent to which movements of the patients take place during dose application should be registered.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/10/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Indication for radiation therapy in the case of a planned radiation therapy at the LMU radiotherapy clinic

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Exclusion Criteria

Contraindications for radiation therapy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Mr.  Prof.  Claus  Belka 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Ms.  Dr. med.  Stefanie  Corradini 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Ms.  Dr. med.  Stefanie  Corradini 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Strahlentherapie und Radioonkologie
    • Mr.  Prof.  Claus  Belka 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.