Clinical trial · Interventional
Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment
Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment (ClinicIMPPACT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of the project is to bring the existing radio frequency ablation (RFA) model for liver cancer treatment (Project IMPPACT, Grant No. 223877, completed in February 2012) into clinical practice. Therefore the project will pursue the following objectives: i) to prove and refine the RFA model in a small clinical study; ii) to develop the model into a real-time patient specific RFA planning and support system for Interventional Radiologists (IR) under special consideration of their clinical workflow needs; iii) to establish a corresponding training procedure for IR's; iv) to evaluate the clinical practicality and benefit of the model for use in the routine workflow in a user survey and expert forum.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RFA therapy simulator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Software assisted RFA treatment
- description
- Non-controlled, prospective, multicenter study arm, to evaluate RFA therapy simulation software.
- interventionNames
- Device: RFA therapy simulator
Primary outcomes (2)
- measure
- 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.
- timeFrame
- All patients within 1 month follow up in the trial period
- description
- For the primary endpoint, the investigators will compare lesions visualized by routine CT one month after ablation with their simulated counterparts to define the accuracy of the method itself. 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. To define the accuracy of the simulation as a parameter, we introduce the following categories: In comparison to the "real ablation" the simulation result would have been: I. much smaller II. comparable III. much larger b) The spatial coordinates of the "real ablation" differs from the simulated one I. Strongly II. Not strongly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available