Artificial Intelligence Assistive Software Tool for Automated Detection and Quantification of Amyloid-Related Imaging Abnormalities.

Importance: Amyloid-related imaging abnormalities (ARIA) are brain magnetic resonance imaging (MRI) findings associated with the use of amyloid-ß-directed monoclonal antibody therapies in Alzheimer disease (AD). ARIA monitoring is important to inform treatment dosing decisions and might be improved through assistive software. Objective: To assess the clinical performance of an artificial intelligence (AI)-based software tool for assisting radiological interpretation of brain MRI scans in patients monitored for ARIA. Design, Setting, and Participants: This diagnostic study used a multiple-reader multiple-case design to evaluate the diagnostic performance of radiologists assisted by the software vs unassisted. The study enrolled 16 US Board of Radiology-certified radiologists to perform radiological reading with (assisted) and without the software (unassisted). The study encompassed 199 retrospective cases, where each case consisted of a predosing baseline and a postdosing follow-up MRI of patients from aducanumab clinical trials PRIME, EMERGE, and ENGAGE. Statistical analysis was performed from April to July 2023. Exposures: Use of icobrain aria, an AI-based assistive software for ARIA detection and quantification. Main Outcomes and Measures: Coprimary end points were the difference in diagnostic accuracy between assisted and unassisted detection of ARIA-E (edema and/or sulcal effusion) and ARIA-H (microhemorrhage and/or superficial siderosis) independently, assessed with the area under the receiver operating characteristic curve (AUC). Results: Among the 199 participants included in this study of radiological reading performance, mean (SD) age was 70.4 (7.2) years; 105 (52.8%) were female; 23 (11.6%) were Asian, 1 (0.5%) was Black, 157 (78.9%) were White, and 18 (9.0%) were other or unreported race and ethnicity. Among the 16 radiological readers included, 2 were specialized neuroradiologists (12.5%), 11 were male individuals (68.8%), 7 were individuals working in academic hospitals (43.8%), and they had a mean (SD) of 9.5 (5.1) years of experience. Radiologists assisted by the software were significantly superior in detecting ARIA than unassisted radiologists, with a mean assisted AUC of 0.87 (95% CI, 0.84-0.91) for ARIA-E detection (AUC improvement of 0.05 [95% CI, 0.02-0.08]; P = .001]) and 0.83 (95% CI, 0.78-0.87) for ARIA-H detection (AUC improvement of 0.04 [95% CI, 0.02-0.07]; P = .001). Sensitivity was significantly higher in assisted reading compared with unassisted reading (87% vs 71% for ARIA-E detection; 79% vs 69% for ARIA-H detection), while specificity remained above 80% for the detection of both ARIA types. Conclusions and Relevance: This diagnostic study found that radiological reading performance for ARIA detection and diagnosis was significantly better when using the AI-based assistive software. Hence, the software has the potential to be a clinically important tool to improve safety monitoring and management of patients with AD treated with amyloid-ß-directed monoclonal antibody therapies.

icobrain ms 5.1: Combining unsupervised and supervised approaches for improving the detection of multiple sclerosis lesions.

Multiple sclerosis (MS) is a chronic autoimmune, inflammatory neurological disease of the central nervous system. Its diagnosis nowadays commonly includes performing an MRI scan, as it is the most sensitive imaging test for MS. MS plaques are commonly identified from fluid-attenuated inversion recovery (FLAIR) images as hyperintense regions that are highly varying in terms of their shapes, sizes and locations, and are routinely classified in accordance to the McDonald criteria. Recent years have seen an increase in works that aimed at development of various semi-automatic and automatic methods for detection, segmentation and classification of MS plaques. In this paper, we present an automatic combined method, based on two pipelines: a traditional unsupervised machine learning technique and a deep-learning attention-gate 3D U-net network. The deep-learning network is specifically trained to address the weaker points of the traditional approach, namely difficulties in segmenting infratentorial and juxtacortical plaques in real-world clinical MRIs. It was trained and validated on a multi-center multi-scanner dataset that contains 159 cases, each with T1 weighted (T1w) and FLAIR images, as well as manual delineations of the MS plaques, segmented and validated by a panel of raters. The detection rate was quantified using lesion-wise Dice score. A simple label fusion is implemented to combine the output segmentations of the two pipelines. This combined method improves the detection of infratentorial and juxtacortical lesions by 14% and 31% respectively, in comparison to the unsupervised machine learning pipeline that was used as a performance assessment baseline.