Evidence-based cross validation for acoustic power transmission for a novel treatment system

Senay Mihcin (Lead / Corresponding author), Jan Strehlow, Daniel Demedts, Michael Schwenke, Yoav Levy, Andreas Melzer

    Research output: Contribution to journalArticle

    2 Citations (Scopus)
    93 Downloads (Pure)

    Abstract

    INTRODUCTION: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice.

    MATERIALS AND METHODS: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation.

    RESULTS: Both systems proved to deliver the power within the accepted efficiency levels (70-90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05).

    CONCLUSIONS: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.

    Original languageEnglish
    Pages (from-to)151-161
    Number of pages14
    JournalMinimally Invasive Therapy and Allied Technologies
    Volume26
    Issue number3
    Early online date13 Jan 2017
    DOIs
    Publication statusPublished - 2017

    Fingerprint

    Acoustics
    Bone and Bones
    Magnetic Resonance Spectroscopy
    Software
    Genetic Complementation Test
    Sonication
    Liver
    Transducers
    Neoplasms
    Safety
    Therapeutics

    Keywords

    • Acoustic power measurement for reliability,
    • Bland-Altman
    • Cross-validation
    • Quality assurance
    • Legislation
    • Pre-clinical MRgFUS
    • Two-sample t-test

    Cite this

    Mihcin, Senay ; Strehlow, Jan ; Demedts, Daniel ; Schwenke, Michael ; Levy, Yoav ; Melzer, Andreas. / Evidence-based cross validation for acoustic power transmission for a novel treatment system. In: Minimally Invasive Therapy and Allied Technologies. 2017 ; Vol. 26, No. 3. pp. 151-161.
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    abstract = "INTRODUCTION: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice.MATERIALS AND METHODS: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation.RESULTS: Both systems proved to deliver the power within the accepted efficiency levels (70-90{\%}). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10{\%} limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05).CONCLUSIONS: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.",
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    note = "This work was supported by the European Community’s Seventh Framework Programmes (FP7/2007-2017) and (FP7/2014-2019) under grant agreement numbers 270186 (FUSIMO project) and 611889 (TRANS-FUSIMO project).",
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    Evidence-based cross validation for acoustic power transmission for a novel treatment system. / Mihcin, Senay (Lead / Corresponding author); Strehlow, Jan; Demedts, Daniel; Schwenke, Michael; Levy, Yoav; Melzer, Andreas.

    In: Minimally Invasive Therapy and Allied Technologies, Vol. 26, No. 3, 2017, p. 151-161.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Evidence-based cross validation for acoustic power transmission for a novel treatment system

    AU - Mihcin, Senay

    AU - Strehlow, Jan

    AU - Demedts, Daniel

    AU - Schwenke, Michael

    AU - Levy, Yoav

    AU - Melzer, Andreas

    N1 - This work was supported by the European Community’s Seventh Framework Programmes (FP7/2007-2017) and (FP7/2014-2019) under grant agreement numbers 270186 (FUSIMO project) and 611889 (TRANS-FUSIMO project).

    PY - 2017

    Y1 - 2017

    N2 - INTRODUCTION: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice.MATERIALS AND METHODS: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation.RESULTS: Both systems proved to deliver the power within the accepted efficiency levels (70-90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05).CONCLUSIONS: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.

    AB - INTRODUCTION: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice.MATERIALS AND METHODS: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation.RESULTS: Both systems proved to deliver the power within the accepted efficiency levels (70-90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05).CONCLUSIONS: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.

    KW - Acoustic power measurement for reliability,

    KW - Bland-Altman

    KW - Cross-validation

    KW - Quality assurance

    KW - Legislation

    KW - Pre-clinical MRgFUS

    KW - Two-sample t-test

    U2 - 10.1080/13645706.2016.1273836

    DO - 10.1080/13645706.2016.1273836

    M3 - Article

    VL - 26

    SP - 151

    EP - 161

    JO - Minimally Invasive Therapy and Allied Technologies

    JF - Minimally Invasive Therapy and Allied Technologies

    SN - 1364-5706

    IS - 3

    ER -