Exploratory Non-Inferiority Validation of an East Asian-Based MRI Brain Volumetric Software

Purpose: Accurate measurement of brain volume using structural magnetic resonance imaging (MRI) is crucial for diagnosing and monitoring of Alzheimer's disease.This study aimed to clinically validate a new MRI-based brain volumetric software (the study software) against a widely used and validated reference software.Materials and Methods: Patients with cognitive impairment who underwent three-dimensional structural brain MRI between January and December 2021 were retrospectively included.The software's performance in detecting significant medial temporal lobe atrophy (MTA), along with the correlation between Scheltens' MTA scores and hippocampal volumes, was assessed using a non-inferiority test and Spearman's correlation analysis, respectively.MTA scores were determined by consensus among three neuroradiologists.Results: A total of 271 patients (mean age 79 7 years [standard deviation], 178 women) were included.The hippocampal volumes calculated by the two software programs were not equivalent.In detecting significant MTA, the study software demonstrated a non-inferior area under the receiver operating characteristic curve (AUC) (0.78 [95% confidence interval (CI): 0.73, 0.84]), accuracy (0.77 [95% CI: 0.72, 0.82]), and specificity (0.89 [95% CI: 0.84, 0.93]) compared to the reference software's AUC (0.71 [95% CI: 0.65, 0.78]), accuracy (0.72 [95% CI: 0.67, 0.78]), and specificity (0.80 [95% CI: 0.73, 0.85]) (p < 0.05).However, non-inferiority in sensitivity was not established between the study software (0.49 [95% CI: 0.38, 0.61]) and reference software (0.55 [95% CI: 0.44, 0.66]).The correlation between MTA scores and hippocampal volume was significantly stronger in the study software ) than in the reference software (-0.30[95% CI: -0.41, -0.19]) (p < 0.05). Conclusion:The new East Asian cohort-based MRI brain volumetric software demonstrated non-inferiority to the reference software in detecting significant MTA.Furthermore, the new study software showed a greater association with the neuroradiologists' MTA scores than the reference software.