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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007631 |
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Date of registration:
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31/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment
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Scientific title:
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Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment - ClinicIMPPACT |
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Date of first enrolment:
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01/03/2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00007631 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Austria
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Finland
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Germany
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Netherlands
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Contacts
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Name:
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Marina
Kolesnik |
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Address:
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Schloss Birlinghoven
53754
Sankt Augustin
Germany |
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Telephone:
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+49-2241-143421 |
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Email:
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marina.kolesnik@fit.fraunhofer.de |
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Affiliation:
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Fraunhofer Institute for Applied Information Technology |
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Name:
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Michael
Moche |
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Address:
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Liebigstr.20
04103
Leipzig
Germany |
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Telephone:
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+49-341-9717558 |
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Email:
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michael.moche@medizin.uni-leipzig.de |
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Affiliation:
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University Hospital LeipzigDepartment of Diagnostic and Interventional Radiology |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of liver and intrahepatic bile ducts
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Secondary malignant neoplasm of liver and intrahepatic bile duct
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C78.7
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Perfusion of liver tissue, liver tumor, liver cancer
C22
C78.7
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Intervention(s)
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Group 1: 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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Primary Outcome(s)
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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(s)
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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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Source(s) of Monetary Support
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European CommissionCommunication Networks, Content and Technology1049 Bruxelles, Belgium
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Ethics review
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Status: Approved
Approval date: 04/06/2015
Contact:
ethik@medizin.uni-leipzig.de
Geschäftsstelle der Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig c/o Zentrale Poststelle
+49-341-9715490
ethik@medizin.uni-leipzig.de
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