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Michael R. Harowicz

Publications and source records attributed to Michael R. Harowicz.

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Transplant-Ready? Evaluating AI Lung Segmentation Models in Candidates with Severe Lung Disease

This study evaluates publicly available deep-learning based lung segmentation models in transplant-eligible patients to determine their performance across disease severity levels, pathology categories, and lung sides, and to identify limitations impacting their use in preoperative planning in lung transplantation. This retrospective study included 32 patients who underwent chest CT scans at Duke University Health System between 2017 and 2019 (total of 3,645 2D axial slices). Patients with standard axial CT scans were selected based on the presence of two or more lung pathologies of varying severity. Lung segmentation was performed using three previously developed deep learning models: Unet-R231, TotalSegmentator, MedSAM. Performance was assessed using quantitative metrics (volumetric similarity, Dice similarity coefficient, Hausdorff distance) and a qualitative measure (four-point clinical acceptability scale). Unet-R231 consistently outperformed TotalSegmentator and MedSAM in general, for different severity levels, and pathology categories (p<0.05). All models showed significant performance declines from mild to moderate-to-severe cases, particularly in volumetric similarity (p<0.05), without significant differences among lung sides or pathology types. Unet-R231 provided the most accurate automated lung segmentation among evaluated models with TotalSegmentator being a close second, though their performance declined significantly in moderate-to-severe cases, emphasizing the need for specialized model fine-tuning in severe pathology contexts.

cs.CV

Virtual Lung Screening Trial (VLST): An In Silico Study Inspired by the National Lung Screening Trial for Lung Cancer Detection

Clinical imaging trials play a crucial role in advancing medical innovation but are often costly, inefficient, and ethically constrained. Virtual Imaging Trials (VITs) present a solution by simulating clinical trial components in a controlled, risk-free environment. The Virtual Lung Screening Trial (VLST), an in silico study inspired by the National Lung Screening Trial (NLST), illustrates the potential of VITs to expedite clinical trials, minimize risks to participants, and promote optimal use of imaging technologies in healthcare. This study aimed to show that a virtual imaging trial platform could investigate some key elements of a major clinical trial, specifically the NLST, which compared Computed tomography (CT) and chest radiography (CXR) for lung cancer screening. With simulated cancerous lung nodules, a virtual patient cohort of 294 subjects was created using XCAT human models. Each virtual patient underwent both CT and CXR imaging, with deep learning models, the AI CT-Reader and AI CXR-Reader, acting as virtual readers to perform recall patients with suspicion of lung cancer. The primary outcome was the difference in diagnostic performance between CT and CXR, measured by the Area Under the Curve (AUC). The AI CT-Reader showed superior diagnostic accuracy, achieving an AUC of 0.92 (95% CI: 0.90-0.95) compared to the AI CXR-Reader's AUC of 0.72 (95% CI: 0.67-0.77). Furthermore, at the same 94% CT sensitivity reported by the NLST, the VLST specificity of 73% was similar to the NLST specificity of 73.4%. This CT performance highlights the potential of VITs to replicate certain aspects of clinical trials effectively, paving the way toward a safe and efficient method for advancing imaging-based diagnostics.

eess.IV

Reproducible Benchmarking for Lung Nodule Detection and Malignancy Classification Across Multiple Low-Dose CT Datasets

Evaluation of artificial intelligence (AI) models for low-dose CT lung cancer screening is limited by heterogeneous datasets, annotation standards, and evaluation protocols, making performance difficult to compare and translate across clinical settings. We establish a public, reproducible multi-dataset benchmark for lung nodule detection and nodule-level cancer classification and quantify cross-dataset generalizability. Using the Duke Lung Cancer Screening (DLCS) dataset as a clinically curated development set, we evaluate performance across LUNA16/LIDC-IDRI, NLST-3D, and LUNA25. Detection models trained on DLCS and LUNA16 were evaluated externally on NLST-3D using free-response ROC analysis. For malignancy classification, we compared five strategies: randomly initialized ResNet50, Models Genesis, Med3D, a Foundation Model for Cancer Biomarkers, and a Strategic Warm-Start (ResNet50-SWS) approach pretrained using detection-derived candidate patches stratified by confidence. Performance was summarized using AUC with 95% confidence intervals and DeLong tests. Detection performance varied substantially by training dataset, with DLCS-trained models outperforming LUNA16-trained models on external NLST-3D evaluation (sensitivity at 2 false positives per scan: 0.72 vs. 0.64; p < 0.001). For malignancy classification, ResNet50-SWS achieved AUCs of 0.71 (DLCS), 0.90 (LUNA16), 0.81 (NLST-3D), and 0.80 (LUNA25), consistently matching or exceeding alternative pretraining strategies. These results demonstrate that dataset characteristics strongly influence lung cancer AI performance and highlight the need for transparent, multi-dataset benchmarking.

cs.CV

Deep Learning for identifying radiogenomic associations in breast cancer

Purpose: To determine whether deep learning models can distinguish between breast cancer molecular subtypes based on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Materials and methods: In this institutional review board-approved single-center study, we analyzed DCE-MR images of 270 patients at our institution. Lesions of interest were identified by radiologists. The task was to automatically determine whether the tumor is of the Luminal A subtype or of another subtype based on the MR image patches representing the tumor. Three different deep learning approaches were used to classify the tumor according to their molecular subtypes: learning from scratch where only tumor patches were used for training, transfer learning where networks pre-trained on natural images were fine-tuned using tumor patches, and off-the-shelf deep features where the features extracted by neural networks trained on natural images were used for classification with a support vector machine. Network architectures utilized in our experiments were GoogleNet, VGG, and CIFAR. We used 10-fold crossvalidation method for validation and area under the receiver operating characteristic (AUC) as the measure of performance. Results: The best AUC performance for distinguishing molecular subtypes was 0.65 (95% CI:[0.57,0.71]) and was achieved by the off-the-shelf deep features approach. The highest AUC performance for training from scratch was 0.58 (95% CI:[0.51,0.64]) and the best AUC performance for transfer learning was 0.60 (95% CI:[0.52,0.65]) respectively. For the off-the-shelf approach, the features extracted from the fully connected layer performed the best. Conclusion: Deep learning may play a role in discovering radiogenomic associations in breast cancer.

cs.CV