Safety of gadobutrol in more than 1,000 pediatric patients: subanalysis of the GARDIAN study, a global multicenter prospective non-interventional study.

BACKGROUND: Gadobutrol is a gadolinium-based contrast agent, uniquely formulated at 1.0 mmol/ml. Although there is extensive safety evidence on the use of gadobutrol in adults, few studies have addressed the safety and tolerability of gadobutrol in pediatric patients. OBJECTIVE: This subanalysis of data from the GARDIAN study evaluated the safety and use of gadobutrol in pediatric patients (age <18 years). MATERIALS AND METHODS: The GARDIAN study was a large phase IV non-interventional prospective multicenter post-authorization safety study performed in Europe, Asia, North America and Africa. A total of 23,708 patients were included who were scheduled to undergo cranial or spinal MRI, liver or kidney MRI, or MR angiography with gadobutrol enhancement. The primary study endpoint was the overall incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) following gadobutrol administration. RESULTS: The GARDIAN study included 1,142 children (age <18 years) who received gadobutrol at a mean dose of 0.13 (range 0.04-0.50) mmol/kg body weight. Gadobutrol was well tolerated in these children, with low rates of ADRs (0.5%) and no SAEs, consistent with results in adults enrolled in the GARDIAN study. Rates of adverse events and ADRs were unrelated to pediatric age or gadobutrol weight-adjusted dose. There were no symptoms suggestive of nephrogenic systemic fibrosis. Investigators rated the contrast quality of gadobutrol-enhanced images as good or excellent in 97.8% of pediatric patients, similar to the main study population. CONCLUSION: Gadobutrol is very well tolerated and provides excellent contrast quality at the recommended weight-adjusted dose in children (age <18 years), similar to the profile in adults.

Effectiveness of Chest CT in Children: CT Findings in Relation to the Clinical Question.

PURPOSE: To estimate the effectiveness and efficiency of chest CT in children based on the suspected diagnosis in relation to the number of positive, negative, and inconclusive CT results. MATERIALS AND METHODS: In this monocentric retrospective study at a university hospital with a division of pediatric radiology, 2019 chest CT examinations (973 patients; median age: 10.5 years; range: 2 days to 17.9 years) were analyzed with regards to clinical data, including the referring department, primary questions or suspected diagnosis, and CT findings. It was identified if the clinical question was answered, whether the suspected diagnosis was confirmed or ruled out, and if additional findings (clinically significant or minor) were detected. RESULTS: The largest clinical subgroup was the hematooncological subgroup (n = 987), with frequent questions for inflammation/pneumonia (66 % in this subgroup). Overall, CT provided conclusive results in 97.6 % of all scans. In 1380 scans (70 %), the suspected diagnosis was confirmed. In 406/2019 cases (20 %), the CT scan was negative also in terms of an additional finding. In 8 of 9 clinical categories, the proportion of positive results was over 50 %. There were predominantly negative results (110/179; 61 %) in pre-stem cell transplant evaluation. In the subgroup of trauma management, 81/144 exams (57 %) showed positive results, including combined injuries (n = 23). 222/396 (56 %) of all additional findings were estimated to be clinically significant. CONCLUSION: In a specialized center, the effectiveness of pediatric chest CT was excellent when counting the conclusive results. However, to improve efficiency, the clinical evaluation before imaging appears crucial to prevent unnecessary CT examinations. KEY POINTS: · Pediatric chest CT in specialized centers has a high diagnostic value.. · CT identifies relevant changes besides the working hypothesis in clinically complex situations.. · Pre-CT clinical evaluation is crucial, especially in the context of suspected pneumonia.. CITATION FORMAT: · Esser M, Tsiflikas I, Kraus MS et al. Effectiveness of Chest CT in Children: CT Findings in Relation to the Clinical Question. Fortschr Röntgenstr 2022; 194: 281 - 290.

Differing Pulmonary Structural Abnormalities Detected on Pulmonary MR Imaging in Cystic Fibrosis Patients with Varying Pancreatic Function.

PURPOSE: In cystic fibrosis (CF) the phenotypic expression of complaints varies widely. Genotypes with sufficient pancreatic function (PS) exhibit milder lung disease compared to CF patients with insufficient pancreatic function (PI). The purpose of this study was to evaluate structural lung disease (SLD) in CF patients with differing pancreatic status but similar results on pulmonary function testing using a pulmonary magnetic resonance imaging score (MR-CF score). MATERIALS AND METHODS: In this retrospective study, 20 patients in our single-center CF database were included: 10 with PS (mean age 12.5 years; six male; BMI 17.4 kg/m2; FeV1 102 %) were matched by gender, age and lung function with 10 PI patients. Experienced observers semi-quantitatively assessed SLD for each lung lobe. The established MR-CF score measures the extent and the severity of bronchiectasis and bronchial wall thickening, mucus plugging, centrilobular opacity, consolidation, sacculation, and air trapping. The total score and sub-score values were compared to the pancreatic status. RESULTS: Patients with CF-PS had overall statistically significant lower MR-CF scores (p = 0.024), and therefore milder SLD, compared to CF-PI. The differences were most significant for bronchiectasis (p = 0.0042) and air trapping (p = 0.0304). SLD was more severe in the upper lobes in all patients. However, differences between CF-PS and CF-PI patients were present in both the upper and lower lung areas (p = 0.0247 and p = 0.0196, respectively). CONCLUSION: Our results demonstrated that CF patients with impaired pancreatic function show more severe lung pathology detected by MRI, especially bronchiectasis and air trapping. KEY POINTS: · Pulmonary MRI offers morphological and functional details without using ionizing radiation. · CF patients with pancreatic insufficiency show more severe pulmonary structural impairment. · Bronchiectasis and air trapping are the most common structural lung changes with predominance in the upper lung lobes.. CITATION FORMAT: · Kraus MS, Teufel M, Esser M et al. Differing Pulmonary Structural Abnormalities Detected on Pulmonary MR Imaging in Cystic Fibrosis Patients with Varying Pancreatic Function. Fortschr Röntgenstr 2020; 192: 567 - 575.

Whole-Body MRI in Children and Adolescents - S1 Guideline. / Ganzkörper-Magnetresonanztomografie im Kindes- und Jugendalter ­ S1-Leitlinie.

Whole-body MRI is an imaging method that uses advanced modern MRI equipment to provide high-resolution images of the entire body. The goal of these guidelines is to specify the indications for which whole-body MRI can be recommended in children and adolescents and to describe the necessary technical requirements. CITATION FORMAT: · Schaefer JF, Berthold LD, Hahn G et al. Whole-Body MRI in Children and Adolescents - S1 Guidelines. Fortschr Röntgenstr 2019; 191: 618 - 625.

Whole-Body [18F]-FDG-PET/MRI for Oncology: A Consensus Recommendation.

Combined PET/MR imaging (PET/MRI) was proposed for patient management in 2006 with first commercial versions of integrated whole-body systems becoming available as of 2010. PET/MRI followed the prior evolution of hybrid imaging as attested by the successful adoption of combined PET/CT and SPECT/CT since the early 2000 s. Today, around 150 whole-body PET/MRI systems have become operational worldwide. One of the main application fields of PET/MRI is oncologic imaging. Despite the increasing use of PET/MRI, little governance regarding standardized PET/MRI protocols has been provided to date. Standardization and harmonization of imaging protocols is, however, mandatory for efficient on-site patient management and multi-center studies. This document summarizes consensus recommendations on key aspects of patient referral and preparation, PET/MRI workflow and imaging protocols, as well as reporting strategies for whole-body [18F]-FDG-PET/MRI. These recommendations were created by early adopters and key experts in the field of PET, MRI and PET/MRI. This document is intended to provide guidance for the harmonization and standardization of PET/ MRI today and to support wider clinical adoption of this imaging modality for the benefit of patients. CITATION FORMAT:: Umutlu L, Beyer T, Grueneisen JS et al. Whole-Body [18F]-FDG-PET/MRI for Oncology: A Consensus Recommendation. Nuklearmedizin 2019, 58: 1-9.

Whole-Body [18F]-FDG-PET/MRI for Oncology: A Consensus Recommendation.

Combined PET/MR imaging (PET/MRI) was proposed for patient management in 2006 with first commercial versions of integrated whole-body systems becoming available as of 2010. PET/MRI followed the prior evolution of hybrid imaging as attested by the successful adoption of combined PET/CT and SPECT/CT since the early 2000 s. Today, around 150 whole-body PET/MRI systems have become operational worldwide. One of the main application fields of PET/MRI is oncologic imaging. Despite the increasing use of PET/MRI, little governance regarding standardized PET/MRI protocols has been provided to date. Standardization and harmonization of imaging protocols is, however, mandatory for efficient on-site patient management and multi-center studies. This document summarizes consensus recommendations on key aspects of patient referral and preparation, PET/MRI workflow and imaging protocols, as well as reporting strategies for whole-body [18F]-FDG-PET/MRI. These recommendations were created by early adopters and key experts in the field of PET, MRI and PET/MRI. This document is intended to provide guidance for the harmonization and standardization of PET/MRI today and to support wider clinical adoption of this imaging modality for the benefit of patients. CITATION FORMAT: · Umutlu L, Beyer T, Grueneisen JS et al. Whole-Body [18F]-FDG-PET/MRI for Oncology: A Consensus Recommendation. Fortschr Röntgenstr 2019; 191: 289 - 297.

Imaging of extralobar pulmonary sequestration in a patient with tetralogy of Fallot with pulmonary atresia, ventricular septal defect and multiple aorto-pulmonary collateral arteries with multidetector computed tomography.

Complex pulmonary vascular blood supply is common in patients with tetralogy of Fallot with pulmonary atresia, major systemic to pulmonary collateral arteries and hypoplastic or deficient central pulmonary arteries. An extralobar lung sequestration, which has not been described previously in these patients, was imaged in a 6-week-old infant with multidetector computed tomography with sub-millimeter resolution. Arterial and venous vessels were analyzed using three-dimensional vascular exploration tools and results were confirmed with cardiac catheterization.