Trial document





This trial has been registered retrospectively.
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  DRKS00009720

Trial Description

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Title

RAD294 - COMPARE Onko PET: Comparison of the diagnostic accuracy of PET/CT and PET/MR in oncological patients

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Trial Acronym

COMPARE Onko PET

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URL of the Trial

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Brief Summary in Lay Language

The detection of suspicious lesions in oncologic patients is challenging and important for further Treatment-decisions.
The aim of this study is to compare the detection-rate of those lesion in PET/CT and PET/MR.

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Brief Summary in Scientific Language

Patients who are scheduled for PET/CT in clinical Routine are additionally scanned with a PET/MR. There is no beed for further Radiation exposure due to MR works without ionising Radiation (radiotracer: TANDEM-principle).
The aim is to compare the detection rates including statistical workup for sensitivity, specificity, PPV, NPV and accuracy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009720
  •   2017/03/16
  •   [---]*
  •   no
  •   Approved
  •   166/15, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   RAD294  (interne Studien-ID)
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Health Condition or Problem studied

  •   any carcinoma requiring PET/CT in clinical routine
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Interventions/Observational Groups

  •   After clinical indicated PET/CT is finished a PET/MR is performed. Further radiation exposure is not necessary.
    When PET/MR is finished the patient leaves the study. There is no follow-up planned.
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Characteristics

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

comparison of the detection rate of primary cancer and metastases

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Secondary Outcome

descriptive statistics including sensitivity, specificity, Positive Predictive Value, Negative Predictive Value and accuracy of PET/CT and PET/MR

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/09
  •   200
  •   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

oncologic patients with clinical indication for PET/CT

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Exclusion Criteria

MR-imcompatibilities

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Klinik für Radiologie und Nuklearmedizin
    • Ms.  Christel  Besseler 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Radiologie und NuklearmedizinUniversität Magdeburg
    • Mr.  Prof.  Jens  Ricke 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting suspended on temporary hold
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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.