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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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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02745600 |
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Date of registration:
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23/03/2016 |
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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
ClinicIMPPACT |
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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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February 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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https://clinicaltrials.gov/show/NCT02745600 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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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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Michael Moche, M.D. |
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Address:
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Telephone:
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00493419717558 |
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Email:
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michael.moche@medizin.uni-leipzig.de |
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Affiliation:
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Name:
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Michael Moche, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Diagnostic and Interventional Radiology, University Leipzig, Leipzig, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- primary or secondary tumors of the liver
- consent of local tumor board stating RFA is best treatment option
- Maximum tumor diameter 3cm
- Maximum of 3 lesions
- Stable extrahepatic tumor manifestation without growth tendency including the
possibility of therapy (e.g. bone, lung metastasis are no contraindication)
- If liver cirrhosis must be compensated Child-Pugh A or B
- written informed consent
Exclusion Criteria:
- Pregnancy and/or breastfeeding
- Severe anaphylactic reaction against iodine and/ or contrast agent
- Insufficient coagulation
- Splenectomy
- Insufficient kidney and thyroid gland function
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Metastases
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Hepatocellular Carcinoma
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Intervention(s)
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Device: RFA therapy simulator
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Primary Outcome(s)
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Comparison of the size and shape, using quantitative and semi-quantitative measures, of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software.
[Time Frame: All patients within 1 month follow up in the trial period]
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Comparison of the spatial coordiantes of the real ablation zone one month after RFA treatment of liver tumors with the simulation results of the ClinicIMPPACT software.
[Time Frame: All patients within 1 month follow up in the trial period]
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Secondary Outcome(s)
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Duration/Efficiency of workflow steps measured in minutes
[Time Frame: up to 60 minutes per lesion]
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Does the follow - up (3, 6 ,12months) imaging support the assumptions regarding local tumor control
[Time Frame: up to 24 months due to 12m follow up]
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Would the treatment protocol been influenced by the simulation results if it would have been known in advance by the treating doctor.
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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