Trial document





This trial has been registered retrospectively.
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  DRKS00016969

Trial Description

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Title

Advanced Image Processing Tools for Motion and Dose Exposure Estimations of the Esophagus in Radiotherapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Stereotactic treatment of tumors is a technique in modern radiotherapy with the aim to irradiate the tumor with high dose single fractions and spare the surrounding healthy tissue. To facilitate the high dose gradient which is necessary to avoid a toxicity of the healthy tissue, high precision throughout the whole workflow is essential.
One risk factor is the motion of organs. During the irradiation of the patient healthy tissue can move into and parts of the tumor can move out of the high dose area. Organ motion also affects the imaging preceding the radiation. In 3D imaging organ motion can cause blurring effects. The blurring effects on the one hand can lead to an under or over estimation of tumor and organ volumes. On the other hand they cause a change in the Hounsfield units in 3D computed tomography (CT) scans which are used to calculate the attenuation in the treatment planning process.
A method to mitigate the blurring is gated imaging. Gated imaging generates one 4D image data-set consisting of multiple 3D image data-sets, which depict organ motion. As the interpretation of 4D data is very time consuming, the current clinical standard is to use the 4D information only for the discrimination of the tumor. To determine the borders of the surrounding tissue solely a 3D image data-set is used. This bears the risk that the motion amplitude of organs is not estimated correctly.
In this work we investigate whether it is sufficient to estimate the volume of organs on a 3D image data-set or if the negligence of motion information from a 4D image data-set can cause higher exposure of the organ to radiation than planned. As an example we have chosen the esophagus depicted by CT because of its bad contrast to surrounding tissue, its radio sensitive mucosa and its motion due during the respiratory or cardiac cycle.

To measure the motion of the esophagus an algorithm will be developed that contours the organ in every 3D data-set of a 4D CT as well as the 3D CT used for treatment planning. Subsequently the single time bins will be registered to get a patient specific motion model of the esophageal motion. The motion model and the contours of the esophagus in addition with the treatment plan allow us to investigate whether the negligence of 4D organ information in the discrimination of the esophagus on CT can cause an increase in radiation exposure of the organ compared to the planned expsoure.

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Organizational Data

  •   DRKS00016969
  •   2019/04/05
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  •   yes
  •   Approved
  •   46/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
  •   central lung tumors
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Interventions/Observational Groups

  •   This study has the aim to measure esophageal motion on 4D CT scans and evaluates whether the current clinical routine (contouring of the esophagus solely on 3D CT scans) covers the motion of the organ or if there is the risk of higher organ dose exposure. This study uses 3D planning CT, one 4D CT and the treatment plan of the enclosed patients with central lung nodules. This study is retrospective and the research will be conducted after patients treatment.
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Characteristics

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

creation of patient specific esophagus motion models with newly developed algorithms

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Secondary Outcome

evaluation of current clinical routine for discrimination of esophagus from surrounding tissues and estimation of motion amplitude

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/02/28
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with treated central lung nodules, 4D CT imaging and in-house stereotactic radio therapy

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Exclusion Criteria

all patients not meeting the inclusion criteria

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Addresses

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    • Department of Radiation Oncology
    • Rober-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    • Department of Radiation Oncology
    • Mr.  Tobias  Fechter 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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    • Department of Radiation Oncology
    • Mr.  DI  Tobias  Fechter 
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Department of Radiation Oncology
    • Robert-Koch-Straße 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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