Software-based versus visual assessment of the minimal ablative margin in patients with liver tumours undergoing percutaneous thermal ablation (COVER-ALL): a randomized phase 2 superiority trial
Abstract
Summary Background: Tumour coverage with optimal minimal ablative margin (MAM) is crucial for improving local control of liver tumours following thermal ablation (TA). The MAM has traditionally been assessed through visual inspection of co-registered computed tomography (CT) images. However, with visual assessment, rates of local tumour control after TA are highly variable. We evaluated the use of a novel software-based method for MAM assessment that incorporates biomechanical deformable image registration and artificial intelligence–based autosegmentation. Methods: This randomized phase 2 superiority trial was conducted at a cancer centre in the USA. Patients 18 years or older with 1 to 3 histology-agnostic liver tumours measuring 1 to 5 cm undergoing CT-guided TA were enrolled. The TA was performed with the aim of achieving a MAM of ≥ 5 mm. Patients were randomly assigned 1:1 to the experimental arm (software-based assessment) and the control arm (visual assessment) using dynamic minimisation to balance covariates. Randomization was performed intraprocedurally after ablation applicator placement. Radiologists assessing oncological outcomes and adverse events were blinded to treatment allocation. All analyses were conducted on an intent-to-treat basis. The primary endpoint was to determine whether the application of the novel software-based method enhances the MAM on post-ablation intraprocedural CT. A preplanned interim analysis for superiority was performed at 50 (50%)…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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