Real-time 3D US-CT fusion-based semi-automatic puncture robot system: clinical evaluation

Conventional systems supporting percutaneous radiofrequency ablation (PRFA) have faced difficulties in ensuring safe and accurate puncture due to issues inherent to the medical images used and organ displacement caused by patients' respiration. To address this problem, this study proposes a semi-automatic puncture robot system that integrates real-time ultrasound (US) images with computed tomography (CT) images. The purpose of this paper is to evaluate the system's usefulness through a pilot clinical experiment involving participants.

For the clinical experiment using the proposed system, an improved U-net model based on fivefold cross-validation was constructed. Following the workflow of the proposed system, the model was trained using US images acquired from patients with robotic arms. The average Dice coefficient for the entire validation dataset was confirmed to be 0.87. Therefore, the model was implemented in the robotic system and applied to clinical experiment.

A clinical experiment was conducted using the robotic system equipped with the developed AI model on five adult male and female participants. The centroid distances between the point clouds from each modality were evaluated in the 3D US-CT fusion process, assuming the blood vessel centerline represents the overall structural position. The results of the centroid distances showed a minimum value of 0.38 mm, a maximum value of 4.81 mm, and an average of 1.97 mm.

Although the five participants had different CP classifications and the derived US images exhibited individual variability, all centroid distances satisfied the ablation margin of 5.00 mm considered in PRFA, suggesting the potential accuracy and utility of the robotic system for puncture navigation. Additionally, the results suggested the potential generalization performance of the AI model trained with data acquired according to the robotic system's workflow.