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Study Protocol STEREOLAB: Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment

  • Study Protocol
  • Interventional Oncology
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Abstract

Purpose

This study aims to evaluate the technical efficacy and local tumor progression-free survival (LTPFS) of a standardized workflow for thermal ablation of colorectal liver metastases (CRLM) consisting of CT during hepatic arteriography (CTHA)-based imaging analysis, stereotactic thermal ablation, and computer-based software assessment of ablation margins.

Materials and Methods

This investigator initiated, single-center, single-arm prospective trial will enroll up to 50 patients (≤ 5 CRLM, Measuring ≤ 5 cm). Procedures will be performed in an angio-CT suite under general anesthesia. The primary objective is to estimate LTPFS with a follow-up of up to 2 years and secondary objectives are analysis of the impact of minimal ablative margins on LTPFS, adverse events, contrast media utilization and radiation exposure, overall oncological outcomes, and anesthesia/procedural time. Adverse events (AE) will be recorded by CTCAE (Common Toxicity Criteria for Adverse Events), and Bayesian optimal phase-2 design will be applied for major intraprocedural AE stop boundaries. The institutional CRLM ablation registry will be used as benchmark for comparative analysis with the historical cohort.

Discussion

The STEREOLAB trial will introduce a high-precision and standardized thermal ablation workflow for CRLM consisting of CT during hepatic arteriography imaging, stereotactic guidance, and ablation confirmation.

Trial Registration ClinicalTrials.gov identifier: (NCT05361551).

Graphical Abstract

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Acknowledgements

We would like to thank iSYS Medizintechnik GmbH (Kitzbühel, Austria) for providing the aiming device.

Funding

This is an investigator-initiated trial.

Author information

Authors and Affiliations

  1. Department of Interventional Radiology, Division of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1471, Houston, TX, USA

    Iwan Paolucci, Jessica Albuquerque Marques Silva, Yuan-Mao Lin & Bruno C. Odisio

  2. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Bryan M. Fellman

  3. Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Kyle A. Jones & Kristy K. Brock

  4. Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Claudio E. Tatsui & Jeffrey S. Weinberg

  5. Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Joseph Ruiz & Jens Tan

  6. Interventionelle Onkologie—Mikroinvasive Therapie (SIP), Medizinische Universität Innsbruck, Innsbruck, Austria

    Reto Bale

Authors
  1. Iwan Paolucci
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  2. Jessica Albuquerque Marques Silva
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  3. Yuan-Mao Lin
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  4. Bryan M. Fellman
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  5. Kyle A. Jones
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  6. Claudio E. Tatsui
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  7. Jeffrey S. Weinberg
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  9. Jens Tan
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  10. Kristy K. Brock
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  11. Reto Bale
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  12. Bruno C. Odisio
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Corresponding author

Correspondence to Bruno C. Odisio.

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Conflict of interest

Kristy Brock received funding from RaySearch Laboratories AB through a Co-Development and Collaboration Agreement. Kristy Brock and Bruno Odisio have a licensing agreement with RaySearch Laboratories AB. Bruno C. Odisio received research grants from Siemens Healthineers. Kristy Brock and Iwan Paolucci received funding through a generous gift from the Apache Corporation. The other authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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For this type of study consent for publication is not required.

Informed Consent

Informed consent will be obtained from all individual participants included in the study.

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Paolucci, I., Albuquerque Marques Silva, J., Lin, YM. et al. Study Protocol STEREOLAB: Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment. Cardiovasc Intervent Radiol 46, 1748–1754 (2023). https://doi.org/10.1007/s00270-023-03524-9

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