Diagnostic value of ultrasound evaluation of major salivary glands for Sjögren's syndrome based on the novel OMERACT scoring system.

OBJECTIVE: The novel Outcome Measures in Rheumatology Clinical Trials (OMERACT) scoring system was used to evaluate the diagnostic effectiveness of major salivary gland ultrasonography (SGUS) for Sjögren's syndrome (SS). MATERIALS AND METHODS: SGUS was performed on the parotid glands (PGs) and submandibular glands of 242 patients (145 patients with SS and 97 patients without SS) using the OMERACT scoring system (grade 0-3). We also evaluated the association of SGUS scores with unstimulated whole salivary flow rate (UWSF), stimulated whole salivary flow rate (SWSF), and labial salivary gland biopsy (LSGB) results. RESULTS: The SGUS scores were significantly higher for the SS group than for the non-SS group (p < 0.001). Using a cutoff value of 8 for the total score yielded the highest sensitivity (76%), specificity (90%), and area under the receiver operating characteristic curve (AUC, 0.828). The correlation between SGUS scores and salivary gland function was moderate to good. A cutoff value of 10 for the total score was more effective in predicting SWSF outcomes than UWSF outcomes (sensitivity: 73% > 58%, specificity: 98% > 87%, and AUC: 0.856 > 0.723). The association of OMERACT scores with LSGB results was fair to moderate. Among 61 anti-SSA-negative patients, 17 had positive PG scores (including ten SS and seven non-SS patients), and 44 had negative PG scores (including 37 non-SS and seven SS patients). CONCLUSION: The OMERACT scoring system had good sensitivity and excellent specificity, demonstrating excellent diagnostic potential for SS and efficacy in assessing salivary gland function. Negative SGUS results may help reduce unnecessary biopsies in anti-SSA-negative patients.

ACR TI-RADS classification combined with number of nodules, halo features optimizes diagnosis and prediction of follicular thyroid cancer.

OBJECTIVES: To investigate the application value of The American College of Radiology (ACR) Thyroid Imaging Reporting and Data System (TI-RADS) category combined with other ultrasound features of nodules in distinguishing follicular thyroid carcinoma (FTC) from thyroid follicular adenoma (FTA). METHODS: We collected and retrospectively analyzed clinical and ultrasound data for 118 and 459 patients with FTCs and FTAs, respectively, at our hospital. Next, we used ACR TI-RADS classification combined with other ultrasound features of nodules to distinguish FTC from FTA. Multivariate Logistic regression was used to screen independent risk factors for FTC, which were subsequently used to construct a nomogram for predicting FTC. RESULTS: ACR TI-RADS categories 4 and 5, unilateral multiple nodules, and halo thickness≥2 mm were independent risk factors for FTC. ACR TI-RADS category combined with number of nodules, halo features of the nodule was a significantly better prediction model for FTC diagnosis (AUC = 0.869) than that of ACR TI-RADS classification alone (AUC = 0.756). CONCLUTIONS: Clinicians need to pay attention to the halo of nodules when distinguishing FTA from FTC. Notably, ACR TI-RADS combined with other nodule ultrasound features has superior predictive performance in diagnosis of FTC compared to ACR TI-RADS classification alone, thus can provide an important reference value for preoperative diagnosis of FTC.

Ultrasonography predicts the results of labial salivary gland biopsy in patients with suspected Sjögren's syndrome: a matrix risk model.

OBJECTIVE: Although a positive result of labial salivary gland biopsy (LSGB) is critical for the diagnosis of Sjögren's syndrome, rheumatologists prefer assessing the non-invasive objective items and hope to learn the predicted probability of positive LSGB before referring patients with suspected Sjögren's syndrome to receive biopsy. This study aimed to explore the predictive value of combined B-mode ultrasonography (US) and shear-wave elastography (SWE) examination on LSGB results. METHODS: A derivation cohort and later a validation cohort of patients with suspected Sjögren's syndrome were recruited. All participants received clinical assessments, B-mode US and SWE examination on bilateral parotid and submandibular glands before LSGB. Positive LSGB was defined by a focus score ⩾1 per 4 mm2 of glandular tissue. RESULTS: In the derivation cohort of 91 participants, either the total US scores or the total SWE values of four glands significantly distinguished patients with positive LSGB from those with negative results (area under the curve (AUC) = 0.956, 0.825, both p < 0.001). The positive predictive value (PPV) was 100% in patients with total US scores ⩾9 or with total SWE values ⩾33 kPa. The negative predictive value (NPV) was 100% in patients with total US scores <5, but 68% in patients with total SWE values <27 kPa. A matrix risk model was derived based on the combination of total US scores and total SWE values. Patients can be stratified into high, moderate, and low risk of positive LSGB. In the validation cohort of 52 participants, the PPV was 94% in the high-risk subpopulation and the NPV was 93% in the low-risk subpopulation. CONCLUSION: A novel matrix risk model based on the combined B-mode US and SWE examination can help rheumatologists to make a shared decision with suspected Sjögren's syndrome patients on whether the invasive procedure of LSGB should be performed.

A measurement method of knee joint space width by ultrasound: a large multicenter study.

BACKGROUND: Although plain radiology is the primary method for assessing joint space width (JSW), it has poor sensitivity to change over time in regards to determining longitudinal progression. We, therefore, developed a new ultrasound (US) measurement method of knee JSW and aimed to provide a monitoring method for the change of JSW in the future. METHODS: A multicenter study was promoted by the Professional Committee of Musculoskeletal Ultrasound, the Ultrasound Society, and the Chinese Medical Doctor Association. US study of knee specimens determined the landmarks for ultrasonic measurement of knee JSW. The US of 1,272 participants from 27 centers was performed to discuss the feasibility and possible influencing factors of knee JSW. The landmarks for US measurement of knee JS, the inflection point of medial femoral epicondyle and the proximal end of the tibia, were determined. RESULTS: The mean knee JSW1 (medial knee JSW) was 8.57±1.95 mm in females and 9.52±2.31 mm in males. The mean knee JSW2 (the near medial knee JSW) was 9.07±2.24 mm in females and 10.17±2.35 mm in males. The JSW values of males were significantly higher than those of females, with a statistical difference. JSW values were negatively correlated with age and body mass index (BMI) to different degrees and positively correlated with height. CONCLUSIONS: The novel US measurement method can be used to measure knee JSW.

Strain Elastography: A Valuable Additional Method to BI-RADS?

BACKGROUND: Breast lesions classified as BI-RADS-US 3 are probably benign and observation was recommended, while a considerable number of BI-RADS-US 4 lesions were benign, resulting in excessive biopsies. We focus exclusively on BI-RADS-US 3 and 4 lesions and hypothesize that improved diagnostic performance can be achieved by integrating real-time elastography (strain ratio) into the BI-RADS-US classification system. METHOD: From April 2010 to September 2015, 1071 lesions were included in the final analysis. After the conventional ultrasound examination, the BI-RADS-US (2013) classification was used to evaluate the lesions. Then the strain ratios were calculated, and the final diagnosis was made on the basis of histological results. The sensitivity, specificity, accuracy, PPV and NPV were calculated and the AUCs were compared. Additionally, an analysis of the diagnostic performance expressed by the pretest and posttest probability of disease (POD) was performed in BI-RADS-US 3 and 4A lesions. RESULTS: With the cutoff point of 2.98, the sensitivity, specificity and accuracy of the strain ratio method were 86.9 %, 86.6 % and 82.6 %, respectively. In BI-RADS-US 3 lesions, a suspicious strain ratio significantly modified the POD from 1.3 % to a posttest POD of 29.8 %. In BI-RADS-US 4A lesions, a suspicious strain ratio significantly modified the POD from 8.5 % to a posttest POD of 48.7 %. CONCLUSION: Ultrasonographic elastography (strain ratio) yields additional diagnostic information in the evaluation of BI-RADS-US 3 and 4 breast lesions. The strain ratios should be integrated into the BI-RADS-US classification system and into daily practice.

B-Mode Ultrasound Combined with Color Doppler and Strain Elastography in the Diagnosis of Non-mass Breast Lesions: A Prospective Study.

Non-mass breast lesions on ultrasound (US) are areas without an associated mass. The purpose of this study was to evaluate whether combining B-mode US with color Doppler US and strain elastography (SE) improves US differentiation between benign and malignant non-mass breast lesions and the decision for biopsy. In this prospective study, three different radiologists analyzed the US images of 77 non-mass lesions independently and recorded Breast Imaging Reporting and Data System (BI-RADS) categories for four data sets. The image characteristics and BI-RADS categories of the four data sets were analyzed by another radiologist. The final diagnosis was made on the basis of pathologic findings. Values for area under the receiver operating curve (AUC), sensitivity, specificity and accuracy were compared among the data sets. The AUC of B-mode US combined with both color Doppler US and SE was greater than that of B-mode US alone (0.666 vs. 0.828) (p = 0.011). The specificity of making the decision for biopsy increased from 6.5% to 38.7% when B-mode US was combined with color Doppler and SE, without a statistically significant change in sensitivity (p < 0.001). Combined use of color Doppler and SE could improve the diagnostic value of B-mode US in distinguishing benign from malignant non-mass breast lesions and the specificity of making the decision for biopsy of non-mass breast lesions.

What Help Could Ultrasound Elastography Give to the Diagnosis of Breast Papillary Lesions?

On the basis of results of our previous studies and the findings of other scholars, the most common histologic type of false-positive diagnosis with strain elastography (SE) was papilloma. The objectives of our study were to evaluate whether SE could contribute to conventional ultrasound differentiation between benign and malignant papillary lesions and between papillary lesions and other common benign breast lesions. Data on 89 papillary lesions at our hospital, including 74 benign and 15 malignant papillary lesions, were included in our study. In addition, 198 non-papillary benign tumors were selected as the control group, including 126 fibroadenomas and 72 cases of fibrocystic mastopathy. All patients gave written informed consent. All patients with breast lesions underwent conventional ultrasound and SE examination. Breast Imaging Recording and Data System (BI-RADS) category and SE score were compared with respect to sensitivity, specificity and accuracy in differentiating between benign and malignant papillary lesions. We then explored the possibility of using BI-RADS combined with SE to differentiate papillary lesions from non-papillary benign tumors. For differentiating between benign and malignant papillary lesions, the area under the receiver operating characteristic curve (AUC) of BI-RADS was 0.568, whereas the AUC values of SE score, strain ratio and BI-RADS combined with SE were 0.517, 0.584 and 0.509, respectively (p > 0.05). For differentiating between papillary lesions and non-papillary benign lesions, the AUC of BI-RADS combined with SE was 0.835, which was higher than the values for BI-RADS (0.775) and SE (SE score: 0.648, strain ratio: 0.661) (p < 0.001). The specificity and accuracy of BI-RADS combined with SE were significantly higher than those for BI-RADS alone without a decrease in sensitivity (p < 0.05). SE could not improve the diagnostic efficiency of BI-RADS in differentiating between benign and malignant papillary lesions. However, BI-RADS combined with SE could improve the specificity of BI-RADS without decrease in sensitivity for differentiating breast papillary lesions from non-papillary benign lesions.

Production and characterization of a novel long-acting Herceptin-targeted nanobubble contrast agent specific for Her-2-positive breast cancers.

BACKGROUND: There is an unmet need for specific and sensitive imaging techniques to assess the efficacy of breast cancer therapy, particularly Her-2-expressing cancers. Ultrasonic microbubbles are being developed for use as diagnostic and therapeutic tools. However, nanobubbles circulate longer, are smaller, and diffuse into extravascular tissue to specifically bind target molecules. Here, we characterize a novel Herceptin-conjugated nanobubble for use against Her-2-expressing tumors. METHODS: Phospholipid-shelled nanobubbles conjugated with Herceptin (NBs-Her) were fabricated using a thin-film hydration method and characterized in vitro in breast cancer cell lines and in vivo in a mouse model. RESULTS: The average size of the unconjugated nanobubbles (NBs-Blank) and NBs-Her was 447.1 ± 18.4 and 613.0 ± 25.4 nm, respectively. In cell culture, the NBs-Her adhered to Her-2-positive cells significantly better than to Her-2-negative cells (p < 0.05). In vivo, the peak intensity and the half-time to washout of the NBs-Her were significantly greater than those of the NBs-Blank (p < 0.05). In addition, contrast-enhanced ultrasound imaging quality was improved through the use of the NBs-Her. The nanobubbles were able to penetrate into tumor tissue to allow extravascular imaging, but did not penetrate normal skeletal muscle. CONCLUSIONS: The Herceptin-conjugated nanobubble had many properties that made it useful for in vivo imaging, including longer circulation time and better tumor selectivity. This platform may be able to provide targeted delivery of therapeutic drugs or genes.

Ultrasound Elastography Combined With BI-RADS-US Classification System: Is It Helpful for the Diagnostic Performance of Conventional Ultrasonography?

PURPOSE: To evaluate the additive diagnostic performance of ultrasound elastography (UE) to ultrasound (US) with the 2003 or 2013 Breast Imaging Reporting and Data System (BI-RADS)-US classification systems for the differentiation of benign and malignant breast lesions. METHODS: From June 2010 to December 2012, 738 women with 770 breast lesions were recruited into this retrospective study. Breast lesions were evaluated separately by US, UE, and both. US assessment was based on the 2003 or 2013 BI-RADS-US, and UE assessment was based on a previously reported 5-point scale. Diagnostic performance of US, UE, and both was compared. RESULTS: Before category 4 lesions were subdivided, the area under the receiver operating characteristic curve (AUC) for US, UE, and both were, respectively, 0.735, 0.877, 0.878 (P < .01). When subcategories of 4 lesions were considered, the AUC for US, UE, and both were, respectively, 0.865, 0.877, and 0.883 (P > .05). Adding UE to analysis of 4A lesions can decrease the percentages of malignancy to 2.56%. CONCLUSION: When the 2003 BI-RADS was considered, UE could give US some help in differentiating breast lesions. However, when the 2013 BI-RADS was considered, UE gave little help to US, although it reduced unnecessary biopsies of benign category 4A lesions.

Could ultrasonic elastography help the diagnosis of breast cancer with the usage of sonographic BI-RADS classification?

OBJECTIVES: The purpose was to evaluate whether BI-RADS (the Breast Imaging Recording and Data System) combined with UE (ultrasound elastography) could improve the differentiation and characterization of benign and malignant breast lesions by comparing with BI-RADS. METHODS: A total of 1080 patients with 1194 breast lesions were studied retrospectively at 8 different institutions from 3 geographic areas across China (North, South, and West) from June 2010 to March 2012. Each institutional ethic review board approved the study and all patients gave written informed consent. All the cases were examined by conventional US (ultrasonography) and UE prior to ultrasound-guided core biopsy. Performance of BI-RADS and BI-RADS combined with UE were compared in different size groups, age groups and area groups. RESULTS: BI-RADS combined with UE cloud improve the accuracy by 13.2% compared to BI-RADS alone for all lesions, 23.2% for <10 mm lesions, 13.3% for ≥10-20 mm lesions, 6.3% for ≥20 mm lesions, 18.4% for <50 years group, 1.7% for ≥50 years group, 13.7% for northern area group, 17.7% for southern area group and 4.4% for western area group. CONCLUSIONS: The help which UE contributed to BI-RADS was greater for breast lesions <10mm and <50 years group.