Impact of Synthetic Lesional MR Images in Automated Focal Cortical Dysplasia Detection in Low‐Data Scenarios

BACKGROUND AND PURPOSE: Automated detection of focal cortical dysplasia (FCD) requires large volumes of voxelwise-lesion-delineated MRI data, which are difficult to acquire. This study aims to generate synthetic MRI data exhibiting FCD, assess its realism, and evaluate its impact on automated FCD detection-particularly in reducing the need for manual annotations. METHODS: T1-weighted (T1w) and T2-weighted-fluid-attenuated inversion recovery (FLAIR) MRI scans from 131 FCD patients and 90 healthy controls from multiple (3) sites were retrospectively studied. Synthetic MRIs were generated by conditioning a generative network on binary FCD mask. Two neuroradiologists identified real images from a random set of 14 real and 14 synthetic scans. Three nnU-Net models were trained to detect FCD using (i) real-only (35-FCD/35-controls), (ii) real (35-FCD/35-controls) + synthetic augmentation, and (iii) expanded real data (70-FCD/70 controls). RESULTS: Experts showed limited ability to distinguish real from synthetic images, with classification accuracy of 60% for T1w and 70% for FLAIR (inter-rater agreement κ = 0.86). Augmenting automated FCD detection with synthetic data increased sensitivity by 8.14% (p = 0.12) and improved model confidence at true lesion sites (0.83 ± 0.11 to 0.89 ± 0.12; p = 0.02). The expanded real-data model further improved sensitivity to 73.8% (p < 0.001) and confidence to 0.90 ± 0.14 (p = 0.01). CONCLUSION: Conditional generative networks can generate realistic synthetic FCD-MRIs, reducing labeled data needs by ∼20% while maintaining equivalent sensitivity. Equivalent amounts of real data, when available, remain more effective than synthetic augmentation.