Objectives: The aim of this study was to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of gadopiclenol, a new high-relaxivity gadolinium-based contrast agent, in children aged 2 to 17 years. Materials and Methods: Children scheduled to undergo contrast-enhanced magnetic resonance imaging of the central nervous system (CNS cohort) or other organs (body cohort) were included sequentially into 3 age groups (12–17, 7–11, and 2–6 years). Gadopiclenol was administered at the dose of 0.05 mmol/kg. A sparse sampling approach was applied, with 4 blood samples per child collected up to 8 hours postinjection. Population PK modeling was used for the analysis, including the CNS cohort and adult subjects from a previous study. Adverse events were recorded, and efficacy was assessed for all children. Results: Eighty children were included, 60 in the CNS cohort and 20 in the body cohort. The 2-compartment model with linear elimination from the central compartment developed in adults was also suitable for children. Pharmacokinetic parameters were very similar between adults and children. Terminal elimination half-life was 1.82 hours for adults and 1.77 to 1.29 hours for age groups 12–17 to 2–6 years. The median clearance ranged from 0.08 L/h/kg in adults and 12–17 years to 0.12 L/h/kg in 2–6 years. The median central and peripheral volumes of distribution were 0.11 to 0.12 L/kg and 0.06 L/kg, respectively, for both adults and children. Simulations of plasma concentrations showed minor differences, and median area under the curve was 590 mg·h/L for adults and 582 to 403 mg·h/L for children. Two patients (2.5%) experienced nonserious adverse events considered related to gadopiclenol: a mild QT interval prolongation and a moderate maculopapular rash. Despite the limited number of patients, this study showed that gadopiclenol improved lesion detection, visualization, and diagnostic confidence. Conclusions: The PK profile of gadopiclenol in children aged 2 to 17 years was similar to that observed in adults. Thus, there is no indication for age-based dose adaptation, and comparable plasma gadopiclenol concentrations are predicted to be achieved with body weight–based dosing in this population. Gadopiclenol at 0.05 mmol/kg seems to have a good safety profile in these patients and could improve lesion detection and visualization, therefore providing better diagnostic confidence.

Magnetic resonance imaging (MRI) of the breast has been increasingly used for the detailed evaluation of breast lesions. Diffusion-weighted imaging (DWI) gives additional information for the lesions based on tissue cellularity. The aim of our study was to evaluate the possibilities of DWI, apparent diffusion coefficient (ADC) value and ADC ratio (the ratio between the ADC of the lesion and the ADC of normal glandular tissue) to differentiate benign from malignant breast lesions. Materials and methods: Eighty-seven patients with solid breast lesions (52 malignant and 35 benign) were examined on a 1.5 T MR scanner before histopathological evaluation. ADC values and ADC ratios were calculated. Results: The ADC values in the group with malignant tumors were significantly lower (mean 0.88 ± 0.15 × 10⁻³ mm²/s) in comparison with the group with benign lesions (mean 1.52 ± 0.23 × 10⁻³ mm²/s). A significantly lower ADC ratio was observed in the patients with malignant tumors (mean 0.66 ± 0.13) versus the patients with benign lesions (mean 1.12 ± 0.23). The cut-off point of the ADC value for differentiating malignant from benign breast tumors was 1.11 × 10⁻³ mm²/s with a sensitivity of 94.23%, specificity of 94.29%, and diagnostic accuracy of 98%, and an ADC ratio of ≤0.87 with a sensitivity of 94.23%, specificity of 91.43%, and a diagnostic accuracy of 95%. Conclusion: According to the results from our study DWI, ADC values and ADC ratio proved to be valuable additional techniques with high sensitivity and specificity for distinguishing benign from malignant breast lesions.

Introduction: A variety of imaging techniques exists for the diagnosis of pancreatic disorders. None of the broadly applied diagnostic methods utilizes elasticity as an indicator of tissue damage. A well-known fact is that both chronic pancreatitis (CP) and pancreatic ductal adenocarcinoma (PDA) are associated with the development of prominent fibrosis (increased tissue stiffness). Purpose: To prospectively assess the accuracy of point shear wave elastography (pSWE) in differentiating between benign and malignant pancreatic diseases, establish a cut-off value for the diagnosis of PDA, and evaluate the influence of certain variables on the obtained results. Materials and methods: The present study included 78 patients who were admitted at the Department of Gastroenterology at the university hospital “Kaspela” between December 2017 and August 2021 for diagnosis and/or treatment of pancreatic disorders. Based on the clinical criteria, diagnostic imaging, and histological findings, patients were divided into the CP and PDA group. The ultrasound based pSWE technique was applied and shear wave velocity (SWV) was measured. The depth of region of interest (ROI) and successful measurement rate were also recorded. Results: The mean ± SD SWV values established through pSWE were 1.75 ± 0.34 m/s and 2.93 ± 0.91 m/s for the CP and PDA, respectively. With a cut-off value of 2.09 m/s, we calculated the sensitivity (Se), specificity (Sp), and accuracy for differentiating between CP and PDA of 89.47%, 91.20%, and 88.60%, respectively. Of the examined variables, BMI and depth of ROI in the CP group and sex in the PDA group showed a statistically significant influence on the obtained results. Conclusions: pSWE may be utilized as a differential diagnostic modality in patients with suspected CP or PDA.

Non-invasive, ultrasound-based methods for visualizing and measuring tissue elasticity are becoming more and more common in routine daily practice. An accurate diagnosis of malignant and benign tumors is essential for determining the appropriate treatment. Despite the wide use of imaging techniques, the investigation for assessing the elasticity of focal liver lesions and their differentiating is still continuing. Aim: To investigate the value of point shear wave elastography (pSWE) and two-dimensional shear wave elastography (2D-SWE) for the differential diagnosis of benign and malignant focal liver lesions. Materials and Methods: A total of 125 adult patients were included from the Clinic of Gastroenterology of University Hospital Kaspela, Plovdiv city, Bulgaria, in the period from January 2021 to July 2022. Participants were divided into two groups—with benign (hemangiomas) and malignant focal liver lesions (hepatocellular carcinoma). The group with benign lesions included 63 patients and the group with malignant focal liver lesions (FLLs)—62 patients. Point shear wave elastography (pSWE) and two-dimensional shear wave elastography (2D-SWE) integrated in the same ultrasound machine (Esaote MyLab™ 9Exp) were performed for each lesion. Results: Malignant FLLs have significantly higher stiffness in both pSWE (2.52–4.32 m/s, 90% CI: 2.37 to 2.68, 90% CI: 4.19 to 4.55) and 2d-SWE (2.52–4.43 m/s, 90% CI: 2.31 to 2.65, 90% CI: 4.27 to 4.61). Conclusion: 2D-SWE and pSWE could provide complementary data about FLLs. They enable us to conveniently and easily obtain accurate stiffness information of FLLs.

Background: This study aims to establish the value of apparent diffusion coefficient maps and other magnetic resonance sequences for active surveillance of prostate cancer. The study included 530 men with an average age of 66, who were under surveillance for prostate cancer. We have used multiparametric magnetic resonance imaging with subsequent transperineal biopsy (TPB) to verify the imaging findings. Results: We have observed a level of agreement of 67.30% between the apparent diffusion coefficient (ADC) maps, other magnetic resonance sequences, and the biopsy results. The sensitivity of the apparent diffusion coefficient is 97.14%, and the specificity is 37.50%. According to our data, apparent diffusion coefficient is the most accurate sequence, followed by diffusion imaging in prostate cancer detection. Conclusions: Based on our findings we advocate that the apparent diffusion coefficient should be included as an essential part of magnetic resonance scanning protocols for prostate cancer in at least bi-parametric settings. The best option will be apparent diffusion coefficient combined with diffusion imaging and T2 sequences. Further large-scale prospective controlled studies are required to define the precise role of multiparametric and bi-parametric magnetic resonance in the active surveillance of prostate cancer.