A prospective development study of software-guided radio-frequency ablation of primary and secondary liver tumors: Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT)

Martin Reinhardt, Philipp Brandmaier, Daniel Seider, Marina Kolesnik, Sjoerd Jenniskens, Roberto Blanco Sequeiros, Martin Eibisberger, Philip Voglreiter, Ronan Flanagan, Panchatcharam Mariappan, Harald Busse, Michael Moche, the ClinicIMPPACT Study Group

Publikation: Beitrag in einer FachzeitschriftArtikelForschungBegutachtung

Abstract

Introduction Radio-frequency ablation (RFA) is a promising minimal-invasive treatment option for early liver cancer, however monitoring or predicting the size of the resulting tissue necrosis during the RFA-procedure is a challenging task, potentially resulting in a significant rate of under- or over treatments. Currently there is no reliable lesion size prediction method commercially available. Objectives ClinicIMPPACT is designed as multicenter-, prospective-, non-randomized clinical trial to evaluate the accuracy and efficiency of innovative planning and simulation software. 60 patients with early liver cancer will be included at four European clinical institutions and treated with the same RFA system. The preinterventional imaging datasets will be used for computational planning of the RFA treatment. All ablations will be simulated simultaneously to the actual RFA procedure, using the software environment developed in this project. The primary outcome measure is the comparison of the simulated ablation zones with the true lesions shown in follow-up imaging after one month, to assess accuracy of the lesion prediction. Discussion This unique multicenter clinical trial aims at the clinical integration of a dedicated software solution to accurately predict lesion size and shape after radiofrequency ablation of liver tumors. Accelerated and optimized workflow integration, and real-time intraoperative image processing, as well as inclusion of patient specific information, e.g. organ perfusion and registration of the real RFA needle position might make the introduced software a powerful tool for interventional radiologists to optimize patient outcomes.

Originalspracheenglisch
Seiten (von - bis)25-32
Seitenumfang8
FachzeitschriftContemporary Clinical Trials Communications
Jahrgang8
DOIs
PublikationsstatusVeröffentlicht - 1 Dez 2017

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Radio
Software
Prospective Studies
Liver
Neoplasms
Liver Neoplasms
Therapeutics
Workflow
Multicenter Studies
Needles
Necrosis
Perfusion
Outcome Assessment (Health Care)
Clinical Trials

Schlagwörter

    ASJC Scopus subject areas

    • !!Medicine(all)
    • Pharmakologie

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    A prospective development study of software-guided radio-frequency ablation of primary and secondary liver tumors : Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT). / Reinhardt, Martin; Brandmaier, Philipp; Seider, Daniel; Kolesnik, Marina; Jenniskens, Sjoerd; Sequeiros, Roberto Blanco; Eibisberger, Martin; Voglreiter, Philip; Flanagan, Ronan; Mariappan, Panchatcharam; Busse, Harald; Moche, Michael; the ClinicIMPPACT Study Group.

    in: Contemporary Clinical Trials Communications, Jahrgang 8, 01.12.2017, S. 25-32.

    Publikation: Beitrag in einer FachzeitschriftArtikelForschungBegutachtung

    Reinhardt, Martin ; Brandmaier, Philipp ; Seider, Daniel ; Kolesnik, Marina ; Jenniskens, Sjoerd ; Sequeiros, Roberto Blanco ; Eibisberger, Martin ; Voglreiter, Philip ; Flanagan, Ronan ; Mariappan, Panchatcharam ; Busse, Harald ; Moche, Michael ; the ClinicIMPPACT Study Group. / A prospective development study of software-guided radio-frequency ablation of primary and secondary liver tumors : Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT). in: Contemporary Clinical Trials Communications. 2017 ; Jahrgang 8. S. 25-32.
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    T2 - Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT)

    AU - Reinhardt, Martin

    AU - Brandmaier, Philipp

    AU - Seider, Daniel

    AU - Kolesnik, Marina

    AU - Jenniskens, Sjoerd

    AU - Sequeiros, Roberto Blanco

    AU - Eibisberger, Martin

    AU - Voglreiter, Philip

    AU - Flanagan, Ronan

    AU - Mariappan, Panchatcharam

    AU - Busse, Harald

    AU - Moche, Michael

    AU - the ClinicIMPPACT Study Group

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    N2 - Introduction Radio-frequency ablation (RFA) is a promising minimal-invasive treatment option for early liver cancer, however monitoring or predicting the size of the resulting tissue necrosis during the RFA-procedure is a challenging task, potentially resulting in a significant rate of under- or over treatments. Currently there is no reliable lesion size prediction method commercially available. Objectives ClinicIMPPACT is designed as multicenter-, prospective-, non-randomized clinical trial to evaluate the accuracy and efficiency of innovative planning and simulation software. 60 patients with early liver cancer will be included at four European clinical institutions and treated with the same RFA system. The preinterventional imaging datasets will be used for computational planning of the RFA treatment. All ablations will be simulated simultaneously to the actual RFA procedure, using the software environment developed in this project. The primary outcome measure is the comparison of the simulated ablation zones with the true lesions shown in follow-up imaging after one month, to assess accuracy of the lesion prediction. Discussion This unique multicenter clinical trial aims at the clinical integration of a dedicated software solution to accurately predict lesion size and shape after radiofrequency ablation of liver tumors. Accelerated and optimized workflow integration, and real-time intraoperative image processing, as well as inclusion of patient specific information, e.g. organ perfusion and registration of the real RFA needle position might make the introduced software a powerful tool for interventional radiologists to optimize patient outcomes.

    AB - Introduction Radio-frequency ablation (RFA) is a promising minimal-invasive treatment option for early liver cancer, however monitoring or predicting the size of the resulting tissue necrosis during the RFA-procedure is a challenging task, potentially resulting in a significant rate of under- or over treatments. Currently there is no reliable lesion size prediction method commercially available. Objectives ClinicIMPPACT is designed as multicenter-, prospective-, non-randomized clinical trial to evaluate the accuracy and efficiency of innovative planning and simulation software. 60 patients with early liver cancer will be included at four European clinical institutions and treated with the same RFA system. The preinterventional imaging datasets will be used for computational planning of the RFA treatment. All ablations will be simulated simultaneously to the actual RFA procedure, using the software environment developed in this project. The primary outcome measure is the comparison of the simulated ablation zones with the true lesions shown in follow-up imaging after one month, to assess accuracy of the lesion prediction. Discussion This unique multicenter clinical trial aims at the clinical integration of a dedicated software solution to accurately predict lesion size and shape after radiofrequency ablation of liver tumors. Accelerated and optimized workflow integration, and real-time intraoperative image processing, as well as inclusion of patient specific information, e.g. organ perfusion and registration of the real RFA needle position might make the introduced software a powerful tool for interventional radiologists to optimize patient outcomes.

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    KW - Perfusion CT

    KW - RFA

    KW - Segmentation

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