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

Authors

Yuan-Mao Lin
Iwan Paolucci
Brian M Anderson
Caleb S O'Connor
Bastien Rigaud
Maria Briones-Dimayuga
Kyle A Jones
Kristy K Brock
Bryan M Fellman
Bruno C Odisio

Publication Date

12-1-2022

Journal

CardioVascular and Interventional Radiology

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.

Keywords

Humans, Ablation Techniques, Catheter Ablation, Liver Neoplasms, Quality of Life, Treatment Outcome, Biomechanical deformable image registration, Liver cancer, Local tumor progression, Minimal ablation margin, Thermal ablation

DOI

10.1007/s00270-022-03255-3

PMID

36058995

PMCID

PMC9712233

PubMedCentral® Posted Date

12-1-2023

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes