Assessment of the Diagnostic Performance of Clinical Examinations and High-Frequency Ultrasound in Patients With Pigmented Skin Tumors.

OBJECTIVES: To investigate whether the integration of high-frequency ultrasound (HFUS) to routine clinical examinations could improve diagnostic performance and management decision for pigmented skin tumors. METHODS: Three general practitioners trained previously and a dermatologist independently assessed pigmented skin tumors and rendered management decision based on clinical examinations alone or clinical examinations integrating HFUS. RESULTS: After integrating HFUS, the diagnostic area under the curve (AUC) (0.658-0.693 versus 0.848, all P < .05) and specificity (46.6-58.6% versus 89.7%, all P < .05) for pigmented skin malignancies were improved for general practitioners, meanwhile unnecessary biopsy rate reduced (42.9-53.6% versus 10.7%, P < .001). To the dermatologist, the diagnostic AUC (0.822 versus 0.949, P < .001), sensitivity (81.7% versus 96.7%, P = .012) and specificity (0.828 versus 0.931, P = .031) improved significantly, meanwhile both missed biopsy rate (14.5% versus 4.8%, P = .031) and unnecessary biopsy rate (19.6% versus 7.1%, P = .016) decreased. Additionally, the diagnostic performance of the general practitioner with integrating HFUS could be comparable with the dermatologist based on clinical examinations alone (all P > .05). CONCLUSIONS: As a complementary tool of clinical examinations, HFUS could help physicians differentiate pigmented skin malignancies and manage decision.

A 5G-based telerobotic ultrasound system provides qualified abdominal ultrasound services for patients on a rural island: a prospective and comparative study of 401 patients.

PURPOSE: To explore the feasibility of a 5G-based telerobotic ultrasound (US) system for providing qualified abdominal US services on a rural island. METHODS: This prospective study involved two medical centers (the tele-radiologist site's hospital and the patient site's hospital) separated by 72 km. Patients underwent 5G-based telerobotic US by tele-radiologists and conventional US by on-site radiologists from September 2020 to March 2021. The clinical feasibility and diagnostic performance of the 5G-based telerobotic abdominal US examination were assessed based on safety, duration, image quality, diagnostic findings, and questionnaires. RESULTS: A total of 401 patients (217 women and 184 men; mean age, 54.96 ± 15.43 years) were enrolled. A total of 90.1% of patients indicated no discomfort with the telerobotic US examination. For the examination duration, telerobotic US took longer than conventional US (12.54 ± 3.20 min vs. 7.23 ± 2.10 min, p = 0.001). For image quality scores, the results of the two methods were similar (4.54 ± 0.63 vs. 4.57 ± 0.61, p = 0.112). No significant differences were found between the two methods in measurements for the aorta, portal vein, gallbladder, kidney (longitudinal diameter), prostate, and uterus; however, telerobotic US underestimated the transverse diameter of the kidney (p < 0.05). A total of 504 positive results, including 31 different diseases, were detected. Among them, 455 cases were identified by the two methods; 17 cases were identified by telerobotic US only; and 32 cases were identified by conventional US only. There was good consistency in the diagnosis of 29 types of disease between the two methods (κ = 0.773-1.000). Furthermore, more than 90% of patients accepted the telerobotic US examination and agreed to pay additional fees in future. CONCLUSION: The 5G-based telerobotic US system can expand access to abdominal US services for patients in rural areas, thereby reducing health care disparities.

Value of conventional ultrasound and shear wave elastography in the assessment of muscle mass and function in elderly people with type 2 diabetes.

OBJECTIVES: We assessed muscle mass and function using ultrasound (US) and shear wave elastography (SWE) for sarcopenia in elderly patients with type 2 diabetes. METHODS: There were 84 patients with type 2 diabetes enrolled in this study; of these, 30 had sarcopenia and 54 did not. We measured appendicular skeletal muscle mass index (ASMI), handgrip strength, calf circumference, 6-m walking speed, and 5-time chair stand test. All patients were in the supine position with their knees in straight and bent poses in turn. The US-derived thickness (Tstraight, Tbent), cross-sectional area (CSAstraight, CSAbent), and SWE (SWEstraight, SWEbent) of the rectus femoris muscle (RFM) were measured and the differences (ΔT, ΔCSA, ΔSWE) were calculated. We assessed the correlations of clinical indicators with US and SWE features. We then compared the clinical indicators and US and SWE features between patients with and without sarcopenia to determine independent predictors. Diagnostic models were established based on these independent predictors. RESULTS: The ASMI was correlated with Tbent (r = 0.57, p < 0.001) and CSAbent (r = 0.50, p < 0.001). Handgrip strength was correlated with Tbent (r = 0.53, p < 0.001) and CSAbent (r = 0.51, p < 0.001). Between patients with and without sarcopenia, the indicators of age, ΔCSA, and ΔSWE were statically different (all p ≤ 0.001). Based on these results, a diagnostic model for sarcopenia was established with 83.3% sensitivity, 83.3% specificity, and 83.3% accuracy. CONCLUSIONS: In elderly people with type 2 diabetes, sarcopenia patients had smaller muscle CSA and less stiffness than non-sarcopenia patients. US and SWE might be useful to screen them. KEY POINTS: • Sarcopenia is common in elderly people with type 2 diabetes. • Ultrasound and shear wave elastography might be useful methods for quantitatively assessing muscle mass and strength. • Ultrasound and shear wave elastography might be useful methods for screening sarcopenia in elderly patients with type 2 diabetes.

Multiparametric ultrasound for the assessment of testicular lesions with negative tumoral markers.

The purpose of this study was to evaluate the diagnostic performance of multiparametric ultrasound (mpUS; grayscale US, color Doppler US, strain elastography, and contrast-enhanced US) in the assessment of testicular lesions with negative tumoral markers. MpUS imaging data, patient age, serum tumor markers, scrotal pain, cryptorchidism, and related clinical information were retrospectively collected for patients who underwent mpUS examination between January 2013 and December 2019. Histologic results or follow-up examinations were used as the reference standard. In total, 83 lesions from 79 patients were included in the analysis. Fifty-six patients were finally diagnosed with benign tumors, and 23 patients were ultimately diagnosed with malignant tumors. Chi-square tests or Fisher's exact tests were used to assess the difference between the two groups. Stepwise multivariate logistic regression analysis showed that lesion diameter (odds ratio [OR] = 1.072, P = 0.005), vascularization on color Doppler US (OR = 4.066, P = 0.001), and hyperenhancement during the early phase (OR = 6.465, P = 0.047) were significant independent risk factors for malignancy; however, when compared with neoplastic lesions, pain (OR = 0.136, P < 0.001), absence of vascularization on color Doppler US (OR = 1.680, P = 0.042), and nonenhancement during the late phase (OR = 3.461, P = 0.031) were strongly associated with nonneoplastic lesions. MpUS features are useful for differentiating testicular lesions with negative tumoral markers and improving the preoperative diagnosis, which may avoid inappropriate radical orchiectomy.

Contrast-enhanced ultrasound in the assessment of Crohn's disease activity: comparison with computed tomography enterography.

BACKGROUND AND OBJECTIVE: Continuous assessment of disease activity remains a huge challenge during the follow-ups of patients with Crohn's disease (CD). In this paper, we aimed to evaluate the performance of contrast-enhanced ultrasound (CEUS) by comparing with computed tomography enterography (CTE) in the assessment of disease activity in CD. MATERIALS AND METHODS: Fifty-two patients diagnosed with CD were included in this study, using the CEUS and CTE as imaging methods for comparison. The selected parameters included the location and thickness of the thickest part of the intestinal wall, mesenteric fat proliferation, mesenteric vessels change, enhancement pattern and the presence of complications. Patients were clinically assessed using the Crohn's disease activity index (CDAI), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Simple endoscopic score for Crohn's disease (SES-CD) was regarded as the reference standard. RESULTS: The location of the thickest part of the intestinal wall (κ = 0.653), bowel wall thickness (ICC = 0.795), mesenteric vessels change (κ = 0.692) and complications (κ = 0.796) displayed substantial agreement (0.61-0.80) between CEUS and CTE, while the detection of mesenteric fat proliferation (κ = 0.395) and enhancement pattern (κ = 0.288) showed fair consistency (0.21-0.40) for comparison. In CEUS, bowel wall thickness, mesenteric fat proliferation, enhancement pattern and mesenteric vessels change were statistically significant in assessing CD activity, while bowel wall thickness, mesenteric fat proliferation and mesenteric vessels change in CTE. Bowel wall thickness showed the best diagnostic performance in the assessment of CD activity at CEUS and CTE. CONCLUSION: CEUS provides a radiation-free and effective way to assess the CD activity in comparison with CTE, which also avoids frequent colonoscopy examinations, improves tolerance of patients, and reduces the cost of medical care, thereby serving as a useful tool for CD follow-up.

Quantitative assessment of crystal dissolution in gout during urate-lowering therapy with computer-aided MicroPure imaging: a cohort study.

BACKGROUND: To evaluate whether MicroPure imaging, an ultrasound (US) image-processing technique with computer-aided analysis, can quantitatively detect crystal dissolution during urate-lowering therapy (ULT) in gout. METHODS: This was a prospective study of gout patients requiring ULT. The first metatarsophalangeal joints were examined using US and MicroPure before and after 3 months of ULT. Elementary lesions of gout, including the double contour sign (DCS), aggregates, tophi, erosion, and other US features were recorded at baseline and 3 months. MicroPure imaging features were automatically calculated by a self-developed software. Patients were divided into goal-achieved and goal-not-achieved groups according to their urate levels at 3 months. The US and MicroPure imaging features of the two groups were analyzed at baseline and 3 months. RESULTS: A total of 55 consecutive patients were enrolled (25: goal-achieved group; 30: goal-not-achieved group). US findings demonstrated that the power Doppler signal grade decreased at 3 months, regardless of the group (both P<0.05). From baseline to 3 months, tophi size and the DCS reduced in the goal-achieved group (both P<0.05), while the US aggregate features showed no difference (P=0.250). However, on the MicroPure imaging, the number and density of aggregates at 3 months decreased in the goal-achieved group (both P<0.05). There were no significant changes at 3 months in any of the MicroPure imaging features in the goal-not-achieved group (all P>0.05). CONCLUSIONS: In comparison with B-mode US, computer-aided MicroPure imaging can sensitively and quantitatively detect aggregate dissolution during effective ULT after only 3 months of treatment.

Prospective assessment of diagnostic efficacy and safety of SonazoidTM and SonoVue® ultrasound contrast agents in patients with focal liver lesions.

OBJECTIVES: To assess the respective diagnostic value of Sonazoid™ and SonoVue® for characterizing FLLs as benign or malignant and the corresponding safety. METHODS: This prospective Phase 3 study was conducted at 17 centres in China and Korea (May 2014 to April 2015); 424 patients (20 to 80 years) with at least 1 untreated focal liver lesion (FLL) (< 10 cm in diameter) underwent a contrast-enhanced ultrasound (CEUS) examination (218 received Sonazoid of 0.12 µL microbubbles/kg; 206 received SonoVue of 2.4 mL). Three independent blinded readers evaluated pre- and post-contrast images characterising the FLLs as benign or malignant. RESULTS: Sonazoid-enhanced and SonoVue-enhanced ultrasound provided a statistically significant improvement in specificity for all 3 readers comparing to unenhanced ultrasound (for Sonazoid: p = 0.0093, < 0.0001, 0.0011; for SonoVue: p = 0.002, 0.03, 0.12, respectively). Difference in accuracy improvement between the 2 groups was within the pre-specified non-inferiority margin of 20% for all 3 readers (6.1%, 95% CI: - 5.0 to 17.2; - 7.5%, 95% CI: - 18.4 to 3.5; - 0.3%, 95% CI: - 11.3 to 10.7). The diagnostic confidence level for all 3 readers increased with post-contrast images relative to pre-contrast images. Both contrast agents were well tolerated. CONCLUSION: Results showed a similar efficacy for Sonazoid™ and SonoVue® in diagnosing FLLs as benign or malignant, and underlined the benefit of CEUS imaging over unenhanced ultrasound imaging in reaching a confident diagnosis without having to refer patients for additional imaging exams.

Assessment of Virtual Touch Tissue Imaging Quantification and the Ultrasound Thyroid Imaging Reporting and Data System in Patients With Thyroid Nodules Referred for Biopsy.

OBJECTIVES: To evaluate the diagnostic performance of Virtual Touch tissue imaging quantification (VTIQ; Siemens Medical Solutions, Mountain View, CA) in combination with the Thyroid Imaging Reporting and Data System (TI-RADS) for assessing thyroid nodules referred for biopsy. METHODS: A total of 197 surgically or cytologically proven thyroid nodules in 187 patients were included. Nodules evaluated by conventional ultrasound (US) and VTIQ examinations were classified into US TI-RADS categories. The shear wave velocity (SWV) on VTIQ was assessed, and the cutoff value was obtained from a receiver operating characteristic curve analysis. Diagnostic performances of conventional US, VTIQ, and their combination were compared. RESULTS: There were 134 benign and 63 malignant nodules. The sensitivity and specificity for the US TI-RADS were 98.4% and 20.1%, respectively. The areas under the receiver operating characteristic curves for the mean, maximum, minimum, and ratio of the SWV were 0.818, 0.805, 0.799, and 0.728. With a cutoff value of 2.90 m/s, the sensitivity and specificity of the mean SWV were 71.4% and 82.8%. By applying this value or less as a standard for downgrading TI-RADS category 4a to category 3 lesions, the specificity significantly rose from 20.1% to 47.0% (P < .001) without a loss of sensitivity. CONCLUSIONS: The additional application of VTIQ can improve the specificity of the TI-RADS for evaluating thyroid nodules without a loss of sensitivity.

Thyroid imaging reporting and data system in assessment of cytological Bethesda Category III thyroid nodules.

OBJECTIVE: To assess the usefulness of thyroid imaging reporting and data system (TI-RADS) for cytological Bethesda Category III thyroid nodules (TNs). METHODS: This retrospective study included 121 patients with 121 TNs classified as Bethesda Category III at fine needle aspiration (FNA) cytology and thereafter underwent surgery. The TNs were classified according to US TI-RADS category and the malignancy risk of each category was calculated. RESULTS: Surgical pathology confirmed 43 (35.5%) malignant and 78 (64.5%) benign TNs. The malignancy risks of categories 3, 4a, 4b, 4c, and 5 TNs were 0%, 4.0%, 12.5%, 62.2%, and 100%, respectively. For those >10 mm (n = 55), the malignancy risks were 0%, 6.2%, 12.5%, 73.3%, and 100%, respectively, whereas for those ≤10 mm (n = 66), the risks were 0%, 0%, 12.5%, 56.7%, and 100%, respectively. CONCLUSION: Bethesda Category III TNs without suspicious US features or those ≤10 mm with only one suspicious US feature can be followed up with US.

Quality of Life and Cost-Effectiveness of Radiofrequency Ablation versus Open Surgery for Benign Thyroid Nodules: a retrospective cohort study.

This study is to compare the health-related quality of life (HRQoL) and cost-effectiveness of radiofrequency ablation (RFA) and open thyroidectomy (OT) for benign thyroid nodules (BTNs) treatment. HRQoL and utility were assessed for 404 BTN patients immediately before treatments (RFA:OT = 137:267) and at 6-month visit. A cost-effectiveness analysis was performed from societal perspective in the China context. Resource use (hospitalization, sick leaves) was collected. We used the net monetary benefit approach and computed cost-effectiveness acceptability curves for RFA and OT. Sensitivity analyses of costs of RFA were performed. At 6-month visit, patients treated with RFA had significantly better HRQoL than patients treated with OT on general health (68.5 versus 66.7, P = 0.029), vitality (71.3 versus 67.5, P < 0.001) and mental health (80.9 versus 79.3, P = 0.038). RFA was more effective than OT in terms of quality-adjusted life-years (QALYs; 0.01QALY/patient) but more expensive (US$823/patient). The probability that RFA would be cost effective at a US$50,000/QALY threshold was 15.5% in China, and it would be increased to 88.4% when price of the RFA device was lowered by 30%. RFA exhibited a significant improvement of HRQoL relative to OT, but is unlikely to be cost effective at its current price in short time.

Role of contrast-enhanced ultrasound in follow-up assessment after ablation for hepatocellular carcinoma.

AIM: To assess the usefulness of contrast-enhanced ultrasound (CEUS) during follow-up after percutaneous ablation therapy for hepatocellular carcinoma (HCC). METHODS: A total of 141 patients with HCCs who received percutaneous ablation therapy were assessed by paired follow-up CEUS and contrast-enhanced computed tomography (CECT). The follow-up scheme was designed prospectively and the intervals between CEUS and CECT examinations were less than 14 d. Both images of follow-up CEUS and CECT were reviewed by radiologists. The ablated lesions were evaluated and classified as local tumor progression (LTP) and LTP-free. LTP was defined as regrowth of tumor inside or adjacent to the successfully treated nodule. The detected new intrahepatic recurrences were also evaluated and defined as presence of intrahepatic new foci. On CEUS and CECT, LTP and new intrahepatic recurrence both were displayed as typical enhancement pattern of HCC (i.e., hyper-enhancing during the arterial phase and washout in the late phase). With CECT as the reference standard, the ability of CEUS in detecting LTP or new intrahepatic recurrence during follow-up was evaluated. RESULTS: During a follow-up period of 1-31 mo (median, 4 mo), 169 paired CEUS and CECT examinations were carried out for the 141 patients. For a total of 221 ablated lesions, 266 comparisons between CEUS and CECT findings were performed. Thirty-three LTPs were detected on CEUS whereas 40 LTPs were detected on CECT, there was significant difference (P < 0.001). In comparison with CECT, the numbers of false positive and false negative LTPs detected on CEUS were 6 and 13, respectively; the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy of CEUS in detecting LTPs were 67.5%, 97.4%, 81.8%, 94.4% and 92.3%, respectively. Meanwhile, 131 new intrahepatic recurrent foci were detected on CEUS whereas 183 were detected on CECT, there was also significant difference (P < 0.05). In comparison with CECT, the numbers of false positive and false negative intrahepatic recurrences detected on CEUS were 13 and 65, respectively; the sensitivity, specificity, PPV, NPV and overall accuracy of CEUS in detecting new intrahepatic recurrent foci were 77.7%, 92.0%, 92.4%, 76.7% and 84.0%, respectively. CONCLUSION: The sensitivity of CEUS in detecting LTP and new intrahepatic recurrence after percutaneous ablation therapy is relatively low in comparison with CECT.