Abstract
Background:
Ultrasonography alone often demonstrates limited accuracy in diagnosing thyroid malignancy. While Strain Elastography (SE) is sensitive and specific, it remains highly operator-dependent. In contrast, shear wave elastography (SWE) provides quantitative tissue stiffness measurements, potentially improving reproducibility. This study aims to directly compare the diagnostic accuracy of SE and SWE in differentiating benign from malignant thyroid nodules, using cytological or histological results as reference standards.
Methods:
We prospectively evaluated 281 patients presenting with thyroid nodules. All nodules were classified based on the ACR-TIRADS ultrasound criteria. Of these, 88 nodules meeting criteria for further assessment underwent fine-needle aspiration (FNA). Each nodule was evaluated with both SE and SWE, and stiffness was quantified by calculating the strain ratio (E2/E1), comparing nodule stiffness to the adjacent sternocleidomastoid muscle. Logistic regression and ROC curve analyses were used to determine the predictive accuracy of each elastography method.
Results:
A strong correlation was observed between SE and SWE (Spearman’s r = 0.363, p < 0.001). ROC analysis revealed comparable performance between SE (sensitivity 80%, specificity 93%) and SWE (sensitivity 80%, specificity 96%), with no significant difference in diagnostic accuracy (ΔAUC = 0.017, p = 0.552). Combining both elastographic techniques yielded an area under the ROC curve (AUC) of 0.906 (95% CI 0.825–0.958), without statistically significant superiority over either method alone.
Conclusions:
SE and SWE demonstrate comparable diagnostic accuracy in distinguishing benign from malignant thyroid nodules, both significantly outperforming conventional ultrasonography. Given their equivalent effectiveness, the choice between SE and SWE may be guided by available resources and expertise, particularly in contexts already utilizing ACR-TIRADS criteria.
Introduction
Ultrasound imaging constitutes a cornerstone in the initial evaluation of thyroid nodules, offering high sensitivity for nodule detection. However, its utility in reliably differentiating benign from malignant lesions remains limited. 1 To augment diagnostic specificity, fine-needle aspiration biopsy (FNAB) is routinely recommended—particularly for nodules ⩾10 mm—based on risk stratification systems such as the Thyroid Imaging Reporting and Data System (TIRADS), which integrate sonographic features indicative of malignancy. 2
One of the classical clinical indicators suggestive of malignancy is increased tissue stiffness or firmness, either detected by manual palpation or via probe compression during ultrasound examination. 3 Historically, this parameter has been evaluated subjectively, relying significantly on the clinician’s experience. The development of ultrasound elastography (USE) has provided a non-invasive and more objective means of assessing tissue stiffness. Among the available techniques, strain elastography (SE) has demonstrated promising diagnostic accuracy, with meta-analyses reporting sensitivity and specificity rates of 92% and 90%, respectively, in the differentiation of malignant thyroid nodules. 4 Nonetheless, the qualitative nature of SE and its inherent operator dependency have raised concerns about reproducibility and clinical reliability, prompting the introduction of quantitative elastography modalities. 5
Point shear wave elastography (pSWE), utilizing Acoustic Radiation Force Impulse (ARFI) technology, represents a quantitative advancement in elastographic imaging by enabling real-time measurement of tissue stiffness. Initially validated for the non-invasive assessment of hepatic fibrosis, ARFI imaging has since been adapted for use in thyroid imaging.6,7 More recently, two-dimensional shear wave elastography (2D-SWE) has emerged as a refined modality offering spatial mapping of stiffness values within thyroid nodules. When integrated with conventional B-mode ultrasonography, 2D-SWE has demonstrated a specificity of 97% and a sensitivity of 81.5% in distinguishing benign from malignant thyroid lesions. 8
Several high-quality reviews have already compared SE and SWE for thyroid nodules. A recent systematic review and meta-analysis summarised diagnostic performance across techniques and platforms, highlighting heterogeneity in study design and technology (pSWE vs 2D-SWE) and the resulting variability in pooled estimates. 9 Earlier meta-analyses focused on SWE alone also reported good accuracy but emphasised methodological and platform-related differences that limit generalisability.10,11 Head-to-head primary studies suggest broadly comparable AUCs for SE and 2D-SWE when applied under standardised conditions. 11
Despite these advancements, tissue stiffness metrics have not yet been incorporated into the TIRADS criteria, which continue to rely solely on grayscale ultrasound features for malignancy risk stratification. Furthermore, uncertainty remains due to (1) heterogeneous inclusion criteria and elastography implementations (pSWE vs 2D-SWE), (2) limited prospective, single-operator, head-to-head designs using the same reference standard within a TIRADS-guided pathway, and (3) scarce evaluation of ratio-based metrics harmonised across SE and SWE. Although stiffness metrics are not included in TIRADS, several studies have explored hybrid approaches that integrate elastography into risk-stratification models. Prospective and retrospective analyses suggest that combining SWE with TIRADS can improve specificity versus TIRADS alone, and new frameworks are being proposed to algorithmically fuse grayscale, elastography, and even radiomic features.12,13 These trends underscore the relevance of clarifying when and how elastography adds value to established risk systems.
The present prospective study addresses these gaps by applying both SE and SWE to the same nodules within an ACR-TIRADS workflow and by analysing a normalised stiffness ratio against the sternocleidomastoid muscle for cross-modality comparability.
The present study aims to assess and compare the diagnostic performance of two ultrasound elastography modalities—strain and SWE—for the differentiation of benign versus malignant thyroid nodules, using cytological or histological findings as the reference standard.
Materials and methods
Patients
A total of 281 patients presenting with thyroid nodules with diameter ⩾1 cm were prospectively evaluated. All nodules were assessed via ultrasonography and categorised according to the American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS). 2 FNAB was conducted in accordance with ACR-TIRADS recommendations, utilising ultrasound guidance. Cytological results were classified according to the Bethesda System, 14 and surgical histopathology was performed for patients undergoing thyroidectomy. Patients with a previous history of thyroid malignancy or those who declined FNAB were excluded. Of the 281 nodules evaluated, only 88 met the predefined ACR-TIRADS criteria for FNAB. Nodules classified as low-risk (e.g. ACR-TIRADS 2 or 3 without suspicious features) were managed conservatively with ultrasound follow-up rather than biopsy. In addition, nodules smaller than 1 cm were excluded from the present analysis, as current American Thyroid Association (ATA) and ACR-TIRADS guidelines generally do not recommend biopsy for subcentimeter nodules unless highly suspicious sonographic features or abnormal cervical lymph nodes are present. This size threshold was adopted to ensure clinical relevance and alignment with international standards. The study was conducted in accordance with the Declaration of Helsinki, and Ethical approval was obtained from the Bioethics Committee (Institutional Review Board) of the Aristotle University of Thessaloniki. Protocol Number 93/2024-16.01.24.
B-mode ultrasound, real-time elastography, and SWE
Ultrasound assessments were performed by a single endocrinologist with extensive expertise (>20 years) in thyroid ultrasonography. Each nodule underwent detailed gray-scale and Doppler ultrasonography, evaluating dimensions (anteroposterior, transverse, longitudinal), shape (wider-than-tall or taller-than-wide), composition (spongiform, solid, cystic, or mixed), echogenicity (hyperechoic, isoechoic, hypoechoic, markedly hypoechoic), margin characteristics (smooth, irregular, lobulated, ill-defined, extrathyroidal extension), and the presence of calcifications or hyperechoic foci (comet-tail artifacts, peripheral, macrocalcifications, microcalcifications). Ultrasound imaging was performed using a LOGIQ P9 ultrasound system (GE Medical Systems, Milwaukee, WI, USA) with an 8–12 MHz multifrequency linear transducer.
Each patient underwent an evaluation with both SE and SWE. For elastographic measurements, the stiffness ratio (E2/E1) was calculated, with E2 representing the stiffness of the thyroid nodule and E1 the adjacent sternocleidomastoid muscle. SE involved applying gentle manual compression with the ultrasound probe to generate tissue strain, assessed through a color-coded strain map. Transverse imaging ensured simultaneous visualisation of nodules and reference muscle tissue for precise strain ratio measurements. In SWE, stiffness quantification was performed by measuring shear wave propagation speed within the tissue, providing stiffness values in kilopascals (kPa) (Figure 1). Multiple measurements (n = 3) were obtained from each nodule, and the mean elasticity value was calculated for analysis. For SWE, E_mean values (mean elasticity, expressed in kilopascals (kPa) were used for statistical analysis, including receiver operating characteristic (ROC) curves, correlation statistics, and threshold evaluations. This choice was based on prior evidence that E_mean provides the most stable and reproducible representation of tissue stiffness across measurements. No conversion between kPa and m/s was required, as stiffness was reported directly in kPa by the ultrasound system.

Strain and shear wave elastography.
Statistical analysis
Continuous data were summarised as median values with interquartile ranges (IQR), while categorical variables were presented as frequencies and percentages. Comparisons of conventional ultrasonographic characteristics, vascular features, and elastographic parameters were performed using the Mann–Whitney U test, Chi-square test, or Fisher's exact test as appropriate. ROC curve analysis was employed to evaluate the diagnostic performance of elastographic methods, calculate optimal cutoff points, and determine sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC). All analyses were conducted with MedCalc statistical software version 19.5.3 (MedCalc Software, Ostend, Belgium), with statistical significance set at p < 0.05.
Results
Between August 2024 and February 2025, a total of 281 consecutive patients with thyroid nodules over 1 cm in diameter were prospectively enrolled in the study. The cohort comprised 224 women (80%) and 57 men (20%), with a mean age of 59.4 years (range, 19–93 years). Detailed descriptive statistics of the patient population are provided in Table 1.
Descriptive statistics of the study population.
Of the enrolled patients, 88 (31%) had nodules meeting criteria for FNAB as indicated by the ACR-TIRADS guidelines. 2 Cytological evaluation categorised 77 nodules (87.5%) as benign (Bethesda II) based on the Bethesda System for Reporting Thyroid Cytology. 14 Eleven patients whose nodules fell into Bethesda categories III–VI underwent surgical excision: (Bethesda III n = 4, Bethesda IV n = 2, Bethesda V n = 2, Bethesda VI n = 3). Histopathological analysis confirmed papillary thyroid carcinoma in all five nodules previously identified cytologically as malignant or suspicious for malignancy (Bethesda V and VI). Patients with benign cytology (Bethesda category II) remained under regular ultrasound follow-up. Demographic and clinical features of patients underwent FNAB are summarised in Table 2. Overall, 6% of them had proven thyroid malignancy according to the thyroidectomy results.
Demographic data, ultrasound, and elastography characteristics of 88 patients where FNA was indicated.
Hypoechoic and very hypoechoic nodules.
Central and Mixed nodular vascularity; P, t-test for independent samples; *, Mann–Whitney U test; ¶, Chi-square test.
The elastography ratio values deviated significantly from normality, as confirmed by the Kolmogorov-Smirnov test (p < 0.05). For this reason, non-parametric methods were applied. Median and interquartile range (IQR) values are presented to better characterize the distribution (Table 2, Figure 2). Spearman’s rank correlation revealed a statistically significant, yet modest, positive correlation between SE and SWE (r = 0.363, p < 0.001; Figures 3 and 4). This magnitude of correlation indicates only a moderate relationship, underscoring that the two modalities cannot be considered interchangeable in clinical decision-making.

Box-and-Whisker plot of elastography ratios.

Correlation of the two elastography techniques.

Bland-Altman Plot compares the two measurement techniques.
Univariate regression analysis was performed on patients who underwent FNAB (n = 88) to evaluate the individual diagnostic performance of SE and SWE in predicting thyroid malignancy. Receiver operating characteristic (ROC) curve analysis indicated comparable diagnostic efficacy for both techniques, as detailed in Table 3.
Diagnostic performance of SWE values and SE and SWE ratios in detecting thyroid malignancy in patients with an indication for FNA.
Pairwise comparison of ROC curves demonstrated no statistically significant difference between SE and SWE (Table 4) elastography ratios (difference between AUCs = 0.017, 95% CI = −0.039 to 0.072, p = 0.552; Figure 5). Further logistic regression analysis evaluating the combined predictive value of SE and SWE (Table 4) yielded an area under the ROC curve (AUC) of 0.906 (95% CI: 0.825–0.958), with sensitivity of 80% and specificity of 98%. However, the combination model did not significantly outperform either SE (p = 0.179) or SWE alone (p = 0.508). When using an absolute SWE stiffness threshold (>27 kPa) for predicting malignancy, sensitivity improved to 100%, albeit with reduced specificity (67%) as illustrated in Figure 5.
Coefficients, odds ratios, and 95% confidence intervals of the combination of the elastography techniques.

Comparison of the ROC of strain and shear-wave elastography in detecting thyroid malignancy.
Discussion
USE has emerged as a promising, non-invasive modality for the assessment of tissue stiffness. 15 Given that malignant thyroid lesions are typically characterised by increased stiffness compared to benign counterparts, 16 USE offers significant potential in differentiating thyroid nodules. The two primary elastographic techniques currently employed in clinical practice are SE and SWE, both of which allow for the evaluation of tissue elasticity and contribute to thyroid nodule characterisation.17,18 As an adjunct to conventional B-mode ultrasound, elastography enhances diagnostic precision, particularly when integrated with fine-needle aspiration (FNA) cytology. 19
Recent clinical guidelines acknowledge the added value of elastography in thyroid nodule assessment. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) recommends incorporating SE into the diagnostic algorithm, citing its high diagnostic performance. 20 Similarly, the World Federation for Ultrasound in Medicine and Biology (WFUMB) supports the use of both qualitative and semi-quantitative elastography techniques for thyroid evaluation. Notably, these guidelines highlight that qualitative elastography improves the specificity of B-mode imaging, while semi-quantitative methods are considered more accessible for clinical implementation. Moreover, SWE has been recognized for its potential to enhance diagnostic specificity, particularly in subcentimeter nodules. 21 SE is widely utilised for evaluating superficial structures such as the thyroid, breast, and prostate, providing insight into elasticity changes associated with pathological processes. 22 In this context, SE measures strain ratios between regions of interest (ROIs), offering a relative quantification of stiffness. In contrast, SWE is a quantitative technique that leverages ARFI to generate shear waves within tissues. 23 The propagation velocity of these waves correlates with tissue stiffness through the Young modulus, enabling both qualitative visualisation and quantitative analysis. SWE has demonstrated the ability to improve specificity in tissue characterisation without compromising sensitivity. 24
Multiple studies have supported the diagnostic utility of SE in evaluating malignant thyroid nodules, often reporting superior accuracy compared to SWE. In our study, SE achieved a sensitivity of 80% and a specificity of 93%, outperforming conventional ultrasound and aligning with findings from prior investigations.25,26 SWE exhibited an equivalent sensitivity (80%) and a slightly higher specificity (96%). A meta-analysis by Hu et al. 27 reported no significant difference in sensitivity between SE and SWE, but SE demonstrated higher specificity and a greater area under the ROC curve (AUC), suggesting superior overall diagnostic performance. In our cohort, however, the two elastography techniques showed comparable performance. This parity may be attributable to the patient selection criteria, as all nodules evaluated had met FNA indications according to ACR-TIRADS. Thus, among suspicious nodules, neither modality demonstrated diagnostic superiority. Our findings are consistent with previous comparative analyses. Borlea et al. 11 likewise reported no significant difference between SE and SWE when directly compared, while emphasizing the reproducibility advantage of SWE. Similarly, Hu et al., 27 in a meta-analysis, found broadly comparable sensitivity across modalities but suggested that SE may offer slightly higher specificity. Taken together, these studies support the view that SE and SWE perform similarly overall, and that practical considerations such as operator experience and system availability largely guide clinical choice.
It should be noted, however, that although SE and SWE were statistically correlated, the correlation was only moderate (r = 0.363). This emphasises that correlation does not imply diagnostic equivalence or interchangeability in clinical practice, and suggests that each modality may provide partly complementary information. Although combining SE and SWE produced an AUC of 0.906 with excellent specificity (98%), this improvement did not reach statistical significance compared with either method alone. As such, the incremental value of dual-mode elastography appears limited. Given that using both techniques increases procedural time and resource utilisation, routine adoption may not be justified unless applied selectively to cases with equivocal findings or low operator confidence. Nevertheless, the slightly higher specificity observed with SWE (96% vs 93% for SE), while not statistically significant, could be of clinical importance when FNA resources are constrained or when specificity is prioritized. Importantly, our study was not powered to detect such modest differences, given that only 88 nodules were cytologically or histologically verified. Thus, any apparent advantage of one modality over the other should be interpreted with caution.
Despite its advantages, elastography is subject to several limitations that may impact on its routine clinical utility. Among the most significant is operator dependency, particularly in SE, which may introduce variability and reduce reproducibility. 28 Conversely, SWE is generally considered less operator-dependent and may offer more consistent results across examiners. Nonetheless, several technical and anatomical factors can influence elastographic measurements. 29 Operator experience, for instance, plays a crucial role in obtaining reliable assessments. In addition, nodule-specific characteristics—such as size, location, and composition—can affect measurement accuracy. 30 Small nodules may yield less reliable strain or stiffness estimates, while large nodules can present heterogeneous elasticity profiles. Nodules located in the isthmus or adjacent to the trachea may be difficult to evaluate due to their anatomical positioning. 31 Furthermore, intranodular calcifications or cystic components may introduce artifacts that confound interpretation. 32 External influences, such as carotid artery pulsations, may also affect image stability and shear wave propagation. 33 These confounding factors underscore the importance of careful technique and interpretation in elastography-based evaluations.
Our study proposes an innovative application of SWE by calculating a stiffness ratio between thyroid nodules and the adjacent sternocleidomastoid muscle, rather than relying solely on absolute kPa values. This ratio-based approach presents several advantages. First, it normalises for inter-individual variability in tissue elasticity, potentially improving reproducibility across diverse patient populations. Second, it facilitates comparison with SE, which also employs a ratio-based assessment, thereby enhancing cross-modality comparability. Third, it mitigates variability related to ultrasound system settings and manufacturer-specific calibration, which can affect absolute SWE measurements.
Cut-off values for distinguishing benign from malignant thyroid nodules vary widely in literature, reflecting heterogeneity in study design, sample size, and prevalence of malignancy. In our study, 31% of nodules met FNA criteria, indicating a population enriched for malignancy risk due to the tertiary referral nature of our center. This introduces a degree of selection bias, which may limit the generalisability of our findings. However, the observed malignancy rate remains within the range reported in broader epidemiological studies. 34 Ultimately, the optimal cut-off value depends on the intended clinical application—whether sensitivity or specificity is prioritised. In our analysis, we selected thresholds that maximized the sum of sensitivity and specificity, in accordance with current ACR-TIRADS recommendations. We propose that these cut-off values be integrated into clinical practice in conjunction with B-mode ultrasound features to guide decision-making regarding FNA. Notably, when applying a stiffness threshold of >27 kPa for SWE, derived from Youden’s index in our dataset, sensitivity reached 100% but specificity decreased to 67%. This illustrates the classical trade-off between minimising false negatives and increasing false positives. Such threshold-based approaches may be tailored to different clinical contexts: in high-risk populations or where missed malignancies are unacceptable, prioritising sensitivity may be justified, whereas in low-resource or low-prevalence settings, higher specificity to reduce unnecessary FNAs may be preferable. A limitation of our study is the absence of subgroup analyses by nodule size, internal composition, or ACR-TIRADS category. These factors are known to influence elastographic measurements and may partially account for variability in sensitivity and specificity reported across studies. Future investigations with larger sample sizes should explore these subgroups, as such analyses could help refine cutoff values and guide more tailored clinical application of elastography. Another limitation is the exclusive reliance on E_mean values for SWE analysis. While E_mean is widely used due to its reproducibility, prior studies suggest that E_max and variability indices may increase sensitivity for detecting heterogeneous nodules. The omission of these parameters, although deliberate for methodological consistency, may have reduced the comprehensiveness of our analysis. Finally, it should be noted that different geographic regions employ distinct thyroid nodule classification systems. For example, in the United Kingdom, thyroid nodule assessment follows the British Thyroid Association (BTA) U-grading system for ultrasound risk stratification, and the Royal College of Pathologists (RCPath) thyroid FNA cytology classification (Thy1–Thy5) instead of the Bethesda system. Such methodological differences may affect direct comparison of diagnostic outcomes across international populations.
Conclusions
In this prospective comparative study, both SE and SWE demonstrated robust diagnostic performance in distinguishing benign from malignant thyroid nodules. Our findings reveal that SE and SWE yield comparable sensitivity and specificity, with no statistically significant difference in overall diagnostic accuracy. The integration of elastographic techniques with ACR-TIRADS ultrasound stratification notably enhances diagnostic confidence, underscoring their complementary value in routine clinical practice.
The novel application of a stiffness ratio between thyroid nodules and adjacent sternocleidomastoid muscle offers a practical and reproducible approach that harmonises SE and SWE metrics. This methodology facilitates cross-modality comparison and mitigates interindividual and system-dependent variability. While both modalities have distinct technical considerations—particularly SE’s operator dependency and SWE’s susceptibility to anatomical artifacts—their equivalent efficacy suggests that clinical adoption may be best guided by local expertise, equipment availability, and specific case characteristics.
Ultimately, elastography represents a valuable adjunct to conventional ultrasound in the risk stratification of thyroid nodules. Future multicenter studies and long-term outcome data are warranted to validate standardized cutoff values and refine elastographic integration into established risk assessment frameworks such as TIRADS.
Footnotes
Acknowledgements
None.
Ethical considerations
The study was conducted in accordance with the Declaration of Helsinki, and Ethical approval was obtained from the Bioethics Committee (Institutional Review Board) of the Aristotle University of Thessaloniki. Protocol Number 93/2024-16.01.24
Consent to participate
All participants provided written informed consent.
Consent for publication
Only de-identified ultrasound images used.
Author contributions
Nikolaos Angelopoulos (1,2,3)
Dimitrios G. Goulis (1,3)
Ioannis Chrisogonidis (1,3)
Ioannis Iakovou (1,3)
Ioannis Androulakis (1,2,3)
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
