Trial document




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  DRKS00000329

Trial Description

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Title

Optimization of the medical diagnostics and therapy managing in colorectal tumors using F-18-Deoxyglucose (FDG) positron emission tomography (PET) and gene expression data (GenPET Colon-2008).

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Trial Acronym

GenPET Colon

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Functional methods like PET/CT provide biological information. FDG is transported into the cells and metabolized (one step) like glucose (sugar), therefore dPET/CT facilitates accurate data about the metabolism. In contrast to the standard use of PET/CT in patients with colorectal carcinomas, we like to perform dynamic measurements. Thus it is possible not only to quantify the metabolism more accurately, but to calculate images of the metabolism. Based on the limited knowledge from the literature, it can be expected that there is a profit for the individual patient. The delineation of tumours is generally improved by parametric imaging. Furthermore, we assume that the tumour classification and the prognostic information about the therapy will be improved by the dPET/CT results. It is planned to perform dPET/CT in 80 patients prior to surgery. The dPET/CT results will be compared to molecular biological data about the tumors as well as the clinical follow up data in order to identify dependencies.

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Brief Summary in Scientific Language

PET/CT with FDG is a method for the primary diagnostics, staging, and therapy monitoring of colorectal carcinomas. The value of dynamic, quantitative measurements (dPET/CT) is still not evaluated in detail regarding the individual profit for the patients. Furthermore, the additional information provided by parametric imaging, which enhances the visualisation of tumours with low glucose metabolism, is only be assessed in a small patient collective. Thus, dPET/CT with FDG is likely to provide a progress regarding diagnostics, staging, and follow up as well as the prognostic information. The tracer is planned to be used in 80 patients with colorectal carcinomas prior to surgery. The dPET/CT results will be compared to gene array results as well as clinical follow up data.

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Organizational Data

  •   DRKS00000329
  •   2010/02/19
  •   [---]*
  •   yes
  •   Approved
  •   S-007/2009, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1113-7528 
  •   S-007/2009  (GenPET Colon-2008)
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Health Condition or Problem studied

  •   C18.0-C18.9
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Interventions/Observational Groups

  •   dynamic PET/CT (dPET/CT) with FDG prior to surgery due to a colorectal carcinoma
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Characteristics

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

recurrent free survival

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Secondary Outcome

individual survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/06/01
  •   80
  •   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 a histologically confirmed primary colorectal carcinoma

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Exclusion Criteria

rejection of the examination by the patient
diabetes mellitus
acute psychosis and other diseases with limited possibilities to understand the examination
pregnant women
claustrophobic patients

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Addresses

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    • Deutsches Krebsforschungszentrum
    • INF 280
    • 69120  Heidelberg
    • Germany
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    •   06221 422500
    •   06221 422476
    •   [---]*
    •   http://www.dkfz.de
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    • Chirurgische Klinik A, Klinikum Ludwigshafen
    • Mr.  Prof. Dr. med.  Stefan  Willis 
    • Bremserstrasse 79
    • 67063  Ludwigshafen
    • Germany
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    • Deutsches Krebsforschungszentrum
    • Mr.  Prof. Dr. med.  Ludwig Georg  Strauss 
    • INF 280
    • 69120  Heidelberg
    • Germany
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    • Deutsches Krebsforschungszentrum
    • Ms.  Prof. Dr. med.  Antonia  Dimitrakopoulou-Strauss 
    • INF 280
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Krebsforschungszentrum
    • INF 280
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.