A Phase 3, Multicenter, Randomized, Controlled Trial to Evaluate Immune Equivalence and Safety of Multidose and Single-dose Formulations of Vi-DT Typhoid Conjugate Vaccine in Healthy Filipino Individuals 6 Months to 45 Years of Age.

Trial Design: Phase 3, randomized, controlled, multicenter, equivalence trial. Methods: Recruitment of participants occurred between 04Februray2020 and 15July2020 at four centers in the Philippines: University of the East - Ramon Magsaysay Memorial Medical Center Inc., Quezon City; University of Philippines Manila - National Institute of Health, Ermita Manila; Asian Hospital and Medical Center, Metro Manila, Philippines Study; and Medical Research Unit, Tropical Disease Foundation, Makati City, Metro Manila, Philippines. Participants: 1800 adults and children 6-months to 45-years of age. Interventions: Participants received a single injection of multidose (MD) or single dose (SD) Vi-DT as test vaccines or meningococcal conjugate vaccine as a comparator. Objective: To evaluate immune equivalence of SD and MD formulations of Vi-DT, and to assess the safety of both formulations compared with comparator vaccine. Outcome Measurement: Blood draw for immunogenicity was performed at baseline prior to vaccine receipt and at four weeks after vaccination for a subset of participants to determine anti-Vi IgG geometric mean titers (GMT) and seroconversion rates. The primary outcome was comparison of anti Vi-IgG seroconversion and GMT between the two formulations of Vi-DT at 4 weeks following vaccine administration. Immune equivalence of MD and SD formulations was confirmed when the two-tailed 95% confidence interval (CI) of the GMT ratio is within [0.67, 1.5] at a two-sided significance level of 0.05. All participants were followed for safety events for six months after vaccine administration. Randomization: Participants were randomized to receive SD Vi-DT, MD Vi-DT, or meningococcal conjugate vaccines in 2.5:2.5:1 allocation ratio. Blinding: Study participants and observers were blinded to treatment assignment. Findings: Immune equivalence of SD (n=252) and MD (n=247) formulations was confirmed by anti-Vi IgG GMT ratio of 1.14 (95%CI: 0.91, 1.43) with respective GMTs in the MD and SD groups of 640.62 IU/mL (95%CI: 546.39, 751.11) and 562.57 IU/mL (95%CI: 478.80, 661.00) (p=0.259). Similarly, anti-Vi IgG seroconversion rate difference between the two formulations of ‒0.43% (95%CI: -4.42, 3.56) confirmed immune equivalence with corresponding seroconversion rates of 98.38% (95%CI: 95.91, 99.37) and 98.81% (95%CI: 96.56, 99.59) in MD and SD Vi-DT formulations, respectively (p=0.722). Both formulations of Vi-DT had a satisfactory safety profile - all five serious adverse events reported during the study were unrelated to the investigational product. Interpretation: The MD and SD formulations of Vi-DT elicited robust and equivalent immune responses following one dose vaccination, and both formulations demonstrated a favorable safety profile. Trial Registration: ClinicalTrials.gov: NCT04204096. Funding: This study was funded by the Bill & Melinda Gates Foundation (OPP 1115556).

Role of Real-Time Elastography in the Evaluation of Cervical Lymph Nodes in Patients with Kikuchi Disease.

The purpose of this study was to compare the use of conventional ultrasound (US) and real-time elastography (RTE) in Kikuchi disease (KD, n = 48) and malignant cervical lymphadenopathy (n = 100) and to evaluate the role of RTE in patients suspected of having KD. In univariate analysis, conventional US revealed each benign feature more frequently in KD than in malignant lymphadenopathy (p < 0.05). However, a considerable number of cases (29, 60.4%) of KD were assessed as malignant with US. KD was assessed as benign by RTE more frequently than malignant lymphadenopathy (37 [77.1%] vs. 37 [37.0%], p < 0.001). In multivariate analysis, perinodal hyper-echogenicity was predictive of KD (odds ratio: 67.25, confidence interval: 10.95-413.04, p < 0.001). There was a tendency for KD to be assessed as malignant with conventional US, but benign with RTE. RTE can help to avoid unnecessary biopsy in patients suspected of having KD on the basis of conventional US.

Cervical Lymph Node Imaging Reporting and Data System for Ultrasound of Cervical Lymphadenopathy: A Pilot Study.

OBJECTIVE: The objective of our study was to compare ultrasound (US) and real-time elastography (RTE) features of benign and malignant cervical lymphadenopathies and propose a structured reporting system for lymph nodes. MATERIALS AND METHODS: The study population for this retrospective study consisted of 291 consecutive patients who underwent US-guided biopsies for cervical lymphadenopathy between 2013 and 2014. The following imaging features were analyzed: shape, margin, echogenicity, echogenic hilum, gross necrosis, calcification, matting, intranodal vascular pattern, elasticity scores (four categories), and strain ratio. A score was assigned for each significant factor from a logistic regression analysis and was multiplied by the beta coefficient. The fitted probability of malignancy was calculated. The risk of malignancy was determined on the basis of the number of suspicious features. Interobserver agreement of the imaging features was retrospectively analyzed using a coefficient of interrater agreement. RESULTS: The imaging features that were significantly associated with malignant lymphadenopathy were round shape, noncircumscribed margin, hyperechogenicity, absence of hilum, gross necrosis, calcification, peripheral or mixed vascularity, high elasticity scores, and high level of strain ratio (p < 0.05). The fitted probability and risk of malignancy increased as the number of suspicious features increased. The risk of malignancy according to the Cervical Lymph Node Imaging Reporting and Data System categories was as follows: category 1, 3.3%; category 2, 10.9%; category 3, 26.7%; category 4, 51.8-74.4%; and category 5, 90.6-98.8%. An analysis of the overall interobserver agreement revealed that interobserver agreement was moderate to good. CONCLUSION: We propose the Cervical Lymph Node Imaging Reporting and Data System, which uses the number of suspicious US and RTE features to assess the risk of malignancy in cervical lymph nodes.

Clinical implications of ultrasound artifacts in the cervicofacial area following injection of permanent facial fillers.

PURPOSE: To evaluate ultrasound (US) findings in the cervicofacial area following injection of permanent facial fillers during a long-term follow-up period. METHODS: Fifty-seven consecutive patients with a history of previous facial filler injection were enrolled at a single institution between 2010 and 2014. All patients were female, and the mean age of the patients was 60.8 years. The mean follow-up period following injection of facial fillers was 16.6 years (range 2-30 years). We analyzed US findings in the face (injection site) and neck (noninjection site). RESULTS: In all patients, face US revealed a snowstorm appearance with strong posterior acoustic shadows and multifocal small anechoic lesions with posterior stepladder artifacts in the subcutaneous fat. Neck US demonstrated the same artifacts as those on the face through local spread of fillers in 14 patients (26.4 %) and abnormal cervical lymph nodes through lymphatic spread in 34 patients (59.6 %). In abnormal cervical lymph nodes, hyperechogenicity and multiple hyperechoic foci were observed in 26 (45.6 %) and 19 (33.3 %) patients, respectively. CONCLUSION: Various artifacts may be demonstrated on US in patients with injection of permanent facial fillers. When hyperechogenicity or multiple hyperehoic foci are seen in cervical lymph nodes, the possibility of migration of facial fillers to the cervical area should be considered.

Detection of an accidentally implanted wooden foreign body using CT: case report and literature review.

Regardless of advancement in imaging techniques, the recognition of vegetative foreign bodies in the abdomen remains a difficult task. Simple radiography and computed tomography will ignore radiolucent foreign bodies. Here, we report the case of a 34-year-old man with a penetrating injury to the abdomen caused by a radiolucent wooden foreign body that was not initially detected. However, imaging can be specific and reliably diagnostic when performed in the appropriate clinical setting. Multidetector computed tomography is frequently underused but has proven useful for the assessment of retained wooden foreign bodies in the abdomen.

Real-time elastography of cervical lymph nodes in Kikuchi disease.

We report, to our knowledge, the first cases of sonographic and real-time elastographic findings of cervical lymph nodes in patients with Kikuchi disease. Cervical lymph nodes had probably benign findings on grayscale sonography and real-time elastography.

Follicular thyroid carcinoma with predominantly cystic formation presenting initially with multiple distant metastases.

Primary malignancies presenting with multiple distant metastases include lung cancer, gastrointestinal malignancy, breast cancer, and prostatic cancer. Multiple distant metastases from follicular thyroid carcinoma (FTC) are uncommon. Cystic formation in FTC is an atypical finding in ultrasonography. The cystic formation of a thyroid nodule is usually considered a benign sonographic finding. We report the case of a 78-year-old man who presented with multiple distant metastases from an FTC with a predominantly cystic formation.

Sonographic findings of high-grade and non-high-grade ductal carcinoma in situ of the breast.

OBJECTIVE: The purpose of this study was to differentiate between high-grade and non-high-grade ductal carcinoma in situ (DCIS) of the breast on sonography. METHODS: From October 2003 to August 2009, 76 DCIS lesions in 73 women who underwent sonography and mammography were included in this study. Lesions were confirmed by mastectomy, breast-conserving surgery, or surgical biopsy. Images were analyzed by 2 radiologists with consensus and were correlated with histologic grades. RESULTS: Of the 76 lesions, 44 were classified as high--grade and 32 as non-high-grade DCIS. Fifty-seven lesions (75.0%) were identified on sonography, which revealed a mass in 30 cases, microcalcifications in 20, ductal changes in 4, and architectural distortion in 3. All cases with false-negative findings on sonography (n = 19) showed microcalcifications on mammography. On sonography, masses were more frequently found in non-high-grade (62.5%) than high-grade DCIS (22.7%; P < .01). No significant difference was seen in the sonographic features of masses between high-grade and non-high-grade DCIS. Microcalcifications were more common in high-grade (43.2%) than non-high-grade (3.1%) DCIS (P = .02). Most sonographically visible microcalcifications had associated findings such as ductal changes (n = 11), a mass (n = 7), or a hypoechoic area (n = 5). The detection rate of microcalcifications on sonography was higher in high-grade (62.9%) than non-high-grade DCIS (25.0%; P = .023). CONCLUSIONS: Microcalcifications with associated ductal changes (11 of 31 [35.5%]) were the most common sonographic findings in high-grade DCIS. An irregular hypoechoic mass with an indistinct and microlobulated margin (13 of 26 [50.0%]) was the most frequent finding in non-high-grade DCIS.

Carcinoma mixed within milk of calcium in a breast: a case report.

Milk of calcium located in the breast is typically a benign entity. However, carcinoma may incidentally arise adjacent to or even within milk of calcium. Consequently, the characteristics of all observed calcific particles should be carefully analyzed. In this study, we report a case of carcinoma presented as malignant microcalcifications mixed within milk of calcium in a breast.