Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment

NCT ID: NCT02745600

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-03-31

Brief Summary

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.

Detailed Description

This ClinicIMPPACT proposal builds upon the success of the IMPPACT project (Grant No. 223877, completed in February 2012), which created a model for facilitating more accurate RFA treatment. This preliminary RFA model was tested in swine, with extensive histological workup, and in a clinical simulation study based on patient data, both of which reported relatively high correlations between estimated and actual tumor volumes. The mapping software for liver cancer RFA was developed through this project and provides a simulator for radiologists to plan, review and optimize procedures. Within IMPPACT, extensive experiments were performed on pigs and cells to develop a micro-scale cellular death model, which we used for calibrating the software. After porcine liver calibration, eight patient lesions were selected from a database of clinical procedures, and the planning software was used retrospectively to simulate interventions and predict lesion shapes. Predicted volumes were then compared against real thermal lesions, visualized and segmented in contrast-enhanced CT one month after ablation. These comparisons showed simulated and real lesion volumes to be acceptably matched after taking virtual tissue perfusion values into account. Some lesion shapes were mismatched, possibly due to inaccuracies in segmenting radiological images.

Treatment with RFA could be improved using a validated software solution to estimate lesion size and identify possible complications in advance-ideally, a solution which is adapted to real-time clinical requirements. However, the current state of the art involves long, hardware-intensive computing time (~5 hours), which is impractical for clinical use.

The main goal of this project is to develop a simulation tool, driven by a user-friendly, ergonomically optimized graphical user interface, to support the complex requirements of clinicians. Therefore, the working steps of this international project and its medical and technical partners are to accelerate simulation speed, optimize needle registration, and integrate patients' individual perfusion values into software calculations, as well as accurate validation techniques, to produce more sophisticated and reliable predictions. The software could also aid in offline planning and simulation and as an RFA teaching tool for radiologists. Its use in retrospective analysis should improve clinical follow up and scientific evaluation.

Conditions

Hepatocellular Carcinoma; Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Software assisted RFA treatment

Non-controlled, prospective, multicenter study arm, to evaluate RFA therapy simulation software.

Group Type: OTHER

RFA therapy simulator

Intervention Type: DEVICE

Computer assisted RFA of liver tumors: Planning, simulation, and follow up,

Interventions

RFA therapy simulator

Computer assisted RFA of liver tumors: Planning, simulation, and follow up,

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: collaborator

University Medical Center Nijmegen

OTHER

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Philipp Brandmaier

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Moche, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Diagnostic and Interventional Radiology, University Leipzig, Leipzig, Germany

Locations

Medical University Graz

Graz, , Austria

Site Status: RECRUITING

University Hospital Turku

Turku, , Finland

Site Status: RECRUITING

Department of Diagnostic and Interventional Radiology, University Leipzig, Germany

Leipzig, Saxony, Germany

Site Status: RECRUITING

Radbound Universität Nijmegen

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Austria; Finland; Germany; Netherlands

Central Contacts

Michael Moche, M.D.

Role: CONTACT

michael.moche@medizin.uni-leipzig.de

00493419717558

Daniel Seider, M.D.

Role: CONTACT

daniel.seider@medizin.uni-leipzig.de

00493419716990

Facility Contacts

Rupert H. Portugaller, M.d.; PhD

Role: primary

Roberto Blanco, M.D.; Ph.D.

Role: primary

Martin Reinhardt, M.D.

Role: primary

martin.reinhardt@medizin.uni-leipzig.de

004934197 ext. 16987

Daniel Seider, M.D:

Role: backup

daniel.seider@medizin.uni-leipzig.de

004934197 ext. 16990

Jürger Fütterer, M.D.; Ph.D.

Role: primary

Other Identifiers

610886

Identifier Type: -

Identifier Source: org_study_id