Medical imaging has allowed for significant advancements in the field of ultrasound procedures over the years. However, each imaging modality exhibits distinct limitations that differently affect their accuracy. It is imperative to ensure the quality of each modality to identify and eliminate these limitations. To achieve this, a tissue-mimicking material (TMM) phantom is utilised for validation. This study aims to perform a systematic analysis of tissue-mimicking materials used for creating ultrasound phantoms. We reviewed 234 studies on the use of TMM phantoms in ultrasound that were published from 2013 to 2023 from two research databases. Our focus was on studies that discussed TMMs’ properties and fabrication for ultrasound, elastography, and flow phantoms. The screening process led to the selection of 16 out of 234 studies to include in the analysis. The TMM ultrasound phantoms were categorised into three groups based on the solvent used; each group offers a broad range of physical properties. The water-based material most closely aligns with the properties of ultrasound. This study provides important information about the materials used for ultrasound phantoms. We also compared these materials to real human tissues and found that PVA matches most of the human tissues the best.

Breast ultrasound elastography phantoms are valued for their ability to mimic human tissue, enabling calibration for quality assurance and testing of imaging systems. Phantoms may facilitate the development and evaluation of ultrasound techniques by accurately simulating the properties of breasts. However, selecting appropriate tissue-mimicking materials for realistic and accurate ultrasound exams is crucial to ensure the ultrasound system responds similarly to real breast tissue. We conducted a systematic review of the PubMed, Scopes, Embase, and Web of Sciences databases, identifying 928 articles in the initial search, of which 19 were selected for further evaluation based on our inclusion criteria. The chosen article focused on tissue-mimicking materials in breast ultrasound elastography phantom fabrication, providing detailed information on the fabrication process, the materials used, and ultrasound and elastography validation of phantoms. The phantoms fabricated from Polyvinyl Chloride Plastisol, silicon, and paraffin were best suited for mimicking breast, fatty, glandular, and parenchyma tissues. Adding scatterers to these materials facilitates accurate fatty and glandular breast tissue simulations, making them ideal for ultrasound quality assurance and elastography training. Future research should focus on developing more realistic phantoms for advanced medical training, improving the practice of difficult procedures, enhancing breast cancer detection research, and providing tailored tissue characteristics.

To evaluate cross-platform measurement consistency and diagnostic threshold requirements in shear wave elastography (SWE), this study presents a robotically controlled, phantom-based validation framework to quantify and interpret inter-vendor variability that limits clinical standardisation. A custom-fabricated polyvinyl chloride-graphite phantom containing eight spherical inclusions (15–25 mm diameter, 25–95 mm depth, 23.53–259.58 kPa stiffness), representing breast tissue mechanical properties, was evaluated using Samsung HS50 and Aixplorer ultrasound systems. Robotic automation standardised probe positioning and contact, eliminating operator-dependent variability and enabling direct, system-level comparison. Cross-platform reproducibility, accuracy against mechanically validated ground truth, and diagnostic threshold performance were assessed across 80 measurements. Both systems demonstrated excellent intra-machine reproducibility (coefficient of variation: Samsung 0.42%, Aixplorer 0.46%) with strong inter-machine correlation (r = 0.9951, p < 0.0001). However, systematic bias of 7.05 kPa and 95% limits of agreement spanning 38.7 kPa revealed substantial cross-platform measurement differences. All phantom inclusions (8/8) measured below their assigned ground truth stiffness on both systems, with systematic underestimation ranging from 0.33 kPa to 109.57 kPa, indicating parameter-dependent measurement distortion linked to inclusion size, depth, and stiffness. Dynamic range compression was observed (Samsung: 68.7%, Aixplorer: 59.1% of true phantom range), providing a mechanistic explanation for diagnostic threshold instability. This study contributes an interpretable validation methodology that links SWE measurement bias to physical lesion properties and imaging system characteristics, rather than relying on correlation alone. Despite strong reproducibility, the observed system-dependent bias demonstrates that SWE measurements are not directly transferable across ultrasound platforms, and system-specific collaboration is required to ensure reliable clinical interpretation.

A polyvinyl chloride (PVC)-based tissue-mimicking polymer phantom was developed and mechanically characterised to replicate stiffness ranges relevant to breast elastography and to provide a controlled platform for evaluating shear wave elastography (SWE) measurements. SWE provides quantitative stiffness information that complements B-mode ultrasound in breast imaging. However, measurement variability related to operator technique and tissue continues to limit confidence in clinical interpretation. This study evaluates the reproducibility of SWE using custom-fabricated PVC-based breast phantoms with mechanically defined stiffness properties. Two PVC-based breast phantoms with identical geometry and different background stiffnesses were scanned using a single ultrasound system under a fixed SWE protocol. Each phantom contained four embedded inclusions representing clinically relevant stiffness categories. Six breast imagers independently acquired repeated SWE measurements in transverse and longitudinal planes, blinded to lesion identity and ground truth. Inter-operator reproducibility was assessed using intraclass correlation coefficients, and was high across both phantom backgrounds, with low intra-operator variability following quality assurance exclusion of one dataset due to sampling error. Measurement variability was lowest for solid inclusions and increased for the cyst-like inclusion in the stiffer background. SWE measurements consistently preserved the relative stiffness ordering of inclusions, although absolute values differed systematically from mechanically derived ground-truth stiffness. These findings demonstrate that PVC-based polymer phantoms provide a stable and reproducible platform for evaluating SWE measurement behaviour under controlled conditions. By isolating operator and acquisition effects from biological variability, this polymer-based framework supports methodological standardisation and structured operator training in breast elastography.