Thyroid Volume Measurement With AI-Assisted Freehand 3D Ultrasound Compared to 2D Ultrasound-A Clinical Trial.

Accurate thyroid volume assessment is critical in thyroid disease diagnostics, yet conventional high-resolution 2D ultrasound has limitations. Freehand 3D ultrasound with AI-assisted segmentation presents a potential advancement, but its clinical accuracy requires validation. This prospective clinical trial included 14 patients scheduled for total thyroidectomy. Preoperative thyroid volume was measured using both 2D ultrasound (ellipsoid method) and freehand 3D ultrasound with AI segmentation. Postoperative thyroid volume, determined via the water displacement method, served as the reference standard. The median postoperative thyroid volume was 14.8 mL (IQR 8.8-20.2). The median volume difference was 1.7 mL (IQR 1.2-3.3) for 3D ultrasound and 3.6 mL (IQR 2.3-6.6) for 2D ultrasound (p = 0.02). The inter-operator reliability coefficient for 3D ultrasound was 0.986 (p < 0.001). These findings suggest that freehand 3D ultrasound with AI-assisted segmentation provides superior accuracy and reproducibility compared to 2D ultrasound and may enhance clinical thyroid volume assessment. ClinicalTrials.gov identifier: NCT05510609.