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

April 21, 2016 updated by: Dr. med. Philipp Brandmaier, University of Leipzig

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University Graz
        • Contact:
          • Rupert H. Portugaller, M.d.; PhD
  • Finland
      • Turku, Finland, 20521
        • Recruiting
        • University Hospital Turku
        • Contact:
          • Roberto Blanco, M.D.; Ph.D.
  • Germany
  • Netherlands
      • Nijmegen, Netherlands, 6500HB
        • Recruiting
        • Radbound Universität Nijmegen
        • Contact:
          • Jürger Fütterer, M.D.; Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Software assisted RFA treatment
Non-controlled, prospective, multicenter study arm, to evaluate RFA therapy simulation software.
Device: RFA therapy simulator
Computer assisted RFA of liver tumors: Planning, simulation, and follow up,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
Time Frame: All patients within 1 month follow up in the trial period

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration/Efficiency of workflow steps measured in minutes
Time Frame: up to 60 minutes per lesion
Duration of the simulation (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.
Time Frame: 12 months

Influence Yes/No

• If yes, is there an expectable potential benefit for the patient due to an increase or decrease of the treatment protocol?
12 months
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

Choice of one of the options below:

  • The tumor is completely treated with sufficient safety margins, healthy tissue has been largely spared by the ablation and there is no locoregional recurrence visible in the follow - up imaging (= locoregional recurrence free - survival).
  • The tumor (incl. safety margins) is completely treated, but lots of healthy tissue has been damaged with the risk of serious complications.
  • The tumor is treated incompletely or there is a visable recurrent tumor in the follow up examination.
up to 24 months due to 12m follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Medical University of Graz
University of Turku
University Medical Center Nijmegen

Investigators

  • Principal Investigator: Michael Moche, M.D., Department of Diagnostic and Interventional Radiology, University Leipzig, Leipzig, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 16, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 610886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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