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Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment

Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment - ClinicIMPPACT

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00007631
Enrollment
60
Registered
2016-03-31
Start date
2016-03-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perfusion of liver tissue, liver tumor, liver cancer C22 C78.7

Interventions

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,

Sponsors

University Hospital LeipzigDepartment of Diagnostic and Interventional Radiology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Austria, Finland, Germany, Netherlands

Contacts

Public ContactMichael Moche

University Hospital LeipzigDepartment of Diagnostic and Interventional Radiology

michael.moche@medizin.uni-leipzig.de+49-341-9717558

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026