Clinical Intervention Modelling, Planning and Proof for Ablation Cancer Treatment

NCT02745600 | Unknown DMC

• 1 other identifier: 610886
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 4

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.

Conditions

Hepatocellular Carcinoma; Liver Metastases

Keywords

RFA; Liver; Ablation Techniques; Treatment Simulation; Computer assisted therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  All patients within 1 month follow up in the trial period

• 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.

  To define the accuracy of the simulation as a parameter, the investigators introduce the following categories: The spatial coordinates of the "real ablation" differs from the simulated one I. Strongly II. Not strongly

  All patients within 1 month follow up in the trial period

Secondary Outcomes (3)

• Duration/Efficiency of workflow steps measured in minutes

  up to 60 minutes per lesion

• Would the treatment protocol been influenced by the simulation results if it would have been known in advance by the treating doctor.

  12 months

• Does the follow - up (3, 6 ,12months) imaging support the assumptions regarding local tumor control

  up to 24 months due to 12m follow up

Study Arms (1)

Software assisted RFA treatment

OTHER

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

Device: RFA therapy simulator

Interventions

RFA therapy simulator DEVICE

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

Software assisted RFA treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy and/or breastfeeding
• Severe anaphylactic reaction against iodine and/ or contrast agent
• Insufficient coagulation
• Splenectomy
• Insufficient kidney and thyroid gland function

Sponsors & Collaborators

• University of Leipzig: lead
• Medical University of Graz: collaborator
• University Medical Center Nijmegen: collaborator
• University of Turku: collaborator

Study Sites (4)

Medical University Graz

Graz, 8036, Austria

RECRUITING

University Hospital Turku

Turku, 20521, Finland

RECRUITING

Department of Diagnostic and Interventional Radiology, University Leipzig, Germany

Leipzig, Saxony, 04103, Germany

RECRUITING

Radbound Universität Nijmegen

Nijmegen, 6500HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Michael Moche, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Moche, M.D.

CONTACT

00493419717558; michael.moche@medizin.uni-leipzig.de

Daniel Seider, M.D.

CONTACT

00493419716990; daniel.seider@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 20, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

FI (1); AU (1); NL (1); DE (1)