Trial document





This trial has been registered retrospectively.
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  DRKS00007631

Trial Description

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Title

Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment

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Trial Acronym

ClinicIMPPACT

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URL of the Trial

http://www.clinicimppact.eu/

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Development and validation of a software - tool for the simulation of radiofrequency ablations (RFA) in the treatment of liver tumors.

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Organizational Data

  •   DRKS00007631
  •   2016/03/31
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  •   yes
  •   Approved
  •   178-15-01062015, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   Perfusion of liver tissue, liver tumor, liver cancer
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C78.7 -  Secondary malignant neoplasm of liver and intrahepatic bile duct
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Interventions/Observational Groups

  •   Perfusion CT of the liver will be carried out.
    Part of the study is to simulate CT -guided radiofrequency ablations (RFA) of the liver. Based on CT data , a patient-specific model is created, which includes not only a pure 3D model of the liver, but also detects physiological parameters.
    The study will serve to evaluate a software environment that is to predict the individual results of RFA for liver tumors accurately, using a simulation based on patient-specific data.
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Characteristics

  •   Non-interventional
  •   Other
  •   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

Comparison of the lesions visualized by routine CT one month after ablation with the simulated ablation.
The coinciding volumes of the real RFA lesion and the simulated one will be determined by counting the number of matching voxels, i.e. voxels of simulation and recorded data, sharing the space coordinates, and dividing by the sum of the voxels of simulated and real lesions.

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Secondary Outcome

The feasibility of the simulation will be analyzed. In particular, the duration of the simulation will be recorded and we will consider whether or not it was short enough to have been used in clinical practice.
To define the potential benefit to the patient, we introduce the following categories:
a) In comparison to the “real ablation” the simulation result would have been: much smaller; comparable; much larger.
b) The spatial coordinates of the “real ablation” differs strongly/not strongly from the simulated one and if the entire lesion is covered with enough safety margin.
The outcome of the patient is divided into the following categories:
I. The tumor (incl. safety margins) is completely treated, but lots of healthy tissue has been damaged.
II. The tumor is treated with sufficient safety margins and healthy tissue has been largely spared by the ablation.
III. The tumor is treated incompletely or there is a viable recurrent tumor in the follow up examination.

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Netherlands
  •   Finland
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/01
  •   60
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

• patients admitted for RFA of a liver tumor (maximum tumor diameter of 3 cm, max. 3 lesions)
• age ≥ 18 years
• written informed consent

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Exclusion Criteria

• known anaphylactic reaction against iodine / contrast agent
• malfunction of the kidney (non treatable renal insufficiency)
• thyroid disease (non treatable hypertyreosis)
• Splenectomy
• pregnant or nursing women
• fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
• concurrent participation in other interventional trials

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Addresses

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    • University Hospital LeipzigDepartment of Diagnostic and Interventional Radiology
    • Mr.  Dr.   Michael  Moche 
    • Liebigstr.20
    • 04103  Leipzig
    • Germany
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    • Fraunhofer Institute for Applied Information Technology
    • Ms.  Dr.  Marina  Kolesnik 
    • Schloss Birlinghoven
    • 53754  Sankt Augustin
    • Germany
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    • University Hospital LeipzigDepartment of Diagnostic and Interventional Radiology
    • Mr.  Dr.  Michael  Moche 
    • Liebigstr.20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • European CommissionCommunication Networks, Content and Technology1049 Bruxelles, Belgium
    • FP7 Rue de la Loi 170
    • 1040  Brüssel
    • Belgium
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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.