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Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions

  • Study Protocol
  • Interventional Oncology
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

This study aims to evaluate the intra-procedural use of a novel ablation confirmation (AC) method, consisting of biomechanical deformable image registration incorporating AI-based auto-segmentation, and its impact on tumor coverage by quantitative three-dimensional minimal ablative margin (MAM) CT-generated assessment.

Materials and methods

This single-center, randomized, phase II, intent-to-treat trial is enrolling 100 subjects with primary and secondary liver tumors (≤ 3 tumors, 1–5 cm in diameter) undergoing microwave or radiofrequency ablation with a goal of achieving ≥ 5 mm MAM. For the experimental arm, the proposed novel AC method is utilized for ablation applicator(s) placement verification and MAM assessment. For the control arm, the same variables are assessed by visual inspection and anatomical landmarks-based quantitative measurements aided by co-registration of pre- and post-ablation contrast-enhanced CT images. The primary objective is to evaluate the impact of the proposed AC method on the MAM. Secondary objectives are 2-year LTP-free survival, complication rates, quality of life, liver function, other oncological outcomes, and impact of AC method on procedure workflow.

Discussion

The COVER-ALL trial will provide information on the role of a biomechanical deformable image registration-based ablation confirmation method incorporating AI-based auto-segmentation for improving MAM, which might translate in improvements of liver ablation efficacy.

Conclusion

The COVER-ALL trial aims to provide information on the role of a novel intra-procedural AC method for improving MAM, which might translate in improvements of liver ablation efficacy.

Trial registration

ClinicalTrials.gov identifier: NCT04083378.

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Funding

This study is funded by the National Institutes of Health grants: 1R01CA235564.

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Authors and Affiliations

  1. Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA

    Yuan-Mao Lin, Iwan Paolucci, Maria Briones-Dimayuga & Bruno C. Odisio

  2. Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, TX, 77030, Houston, USA

    Brian M. Anderson, Caleb S. O’Connor, Bastien Rigaud, Kyle A. Jones & Kristy K. Brock

  3. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX, 77030, USA

    Bryan M. Fellman

Authors
  1. Yuan-Mao Lin
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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 has a licensing agreement with RaySearch Laboratories AB.

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

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Lin, YM., Paolucci, I., Anderson, B.M. et al. Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions. Cardiovasc Intervent Radiol 45, 1860–1867 (2022). https://doi.org/10.1007/s00270-022-03255-3

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  • DOI: https://doi.org/10.1007/s00270-022-03255-3

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