Trial document




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  DRKS00009224

Trial Description

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Title

Evaluation of prompt-gamma imaging for range verification for the proton irradiation of tumor patients

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Trial Acronym

Prima

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is addressed to patients who receive a proton therapy as part of their oncological treatment. Aim of the study is the detection of the range of the proton in the patient and the evaluation of the novel method of prompt gamma imaging.

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Brief Summary in Scientific Language

Several factors show a significant influence on the dose distribution and especially the proton range in patient, such as anatomical variation of tumor region, uncertainties in patient positioning, internal movement of organs and the quality of CT scan. Thus, a current scientific challenge is the spatial measurement of dose distribution and surrogates of the dose during clinical patient irradiation. Different technical solutions which promise such as measurements are in realization. One approach based on the detection of secondary created prompt gamma radiation, which arise promptly and allows a synchronously evaluation of the applied proton irradiation. Aim of the presented study is the assessment of the used detection method and the applied prompt gamma camera which allows the detection of prompt gamma radiation synchronously to the proton irradiation. With the aid of this study the question should be answered how far the applied method gives additional and useful information about proton range in clinical application and if the method of prompt gamma imaging improves the precision of proton therapy.

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Organizational Data

  •   DRKS00009224
  •   2015/08/28
  •   [---]*
  •   yes
  •   Approved
  •   EK181042015, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   All oncological diseases with indication for proton therapy.
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   The prompt gamma radiation will be detected by the prompt gamma camera in patients who are irradiated with protons.
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Characteristics

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

Post-therapeutic evaluation of proton range based on the measured spatial prompt gamma ray distribution

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Secondary Outcome

No

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/13
  •   50
  •   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

Indications for proton therapy

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Exclusion Criteria

No indications for proton therapy

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Addresses

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    • Universitätsklinikum DresdenKlinik und Poliklinik für Strahlentherapie und RadioonkologieOncoRay Dresden
    • Mr.  Prof.  Michael  Baumann 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    •   [---]*
    •   [---]*
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    •   [---]*
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    • OncoRay Dresden
    • Mr.  Dr.  Christian  Richter 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Klinisches Studienzentrum
    • Ms.  Annett  Klöber 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Universitätsklinikum Carl Gustav Carus
    • Fetscherstr. 74
    • 01307  Dresden
    • 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.