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 their realism, and evaluate their 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 masks. 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) plus 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 kappa = 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 approximately 20% while maintaining equivalent sensitivity. Equivalent amounts of real data, when available, remain more effective than synthetic augmentation.