Publications by authors named "Endrikat J"
Objective: To analyse the potential impact of patients' sex, race, and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide.
Methods: Two analyses were performed. (1) The "Phase-IV-Analysis" evaluated an integrated pooled database of 4 non-interventional studies.
Awareness of Breast Cancer Risk Factors in Women with vs. Without High Breast Density.
Patient Prefer Adherence
July 2024
Purpose: Women with high breast density (HBD) carry an increased risk for breast cancer (BC). The aim of the study was to provide data on awareness and knowledge gaps among women with vs w/o HBD about BC risk factors (BCRFs), which is the basis for effective communication about screening.
Patients And Methods: This was a web-based survey of 3000 women aged ≥30 and ≤70 from six countries.
Article Synopsis
- Gadobutrol, a gadolinium-based contrast agent introduced in 1998, has been administered over 100 million times, leading to extensive safety data collection.
- A review of safety data from clinical studies and postmarketing surveillance revealed low rates of adverse events (AEs), with drug-related AEs reported in 3.4% of patients, and serious AEs in less than 0.1%.
- The analysis found that adverse drug reactions (ADRs) were rare, with no significant increase in AEs in at-risk populations, including children and the elderly.
Background: Gadobutrol has been administered more than 100 million times worldwide, since February 1998, that is, over the last 25 years. Numerous clinical studies in a broad range of indications document the long-term experience with gadobutrol.
Objective: The aim of this study was to provide a literature-based overview on gadobutrol's efficacy in 9 approved indications and use in children.
Background: Contrast-enhanced mammography (CEM) is an emerging breast imaging modality. Clinical data is scarce.
Objectives: To summarize clinical evidence on the use of iopromide in CEM for the detection or by systematically analyzing the available literature on efficacy and safety.
Background: The impact of certain tumor parameters on the sensitivity of imaging tools is unknown. The purpose was to study the impact of breast cancer histology, tumor grading, single receptor status, and molecular subtype on the sensitivity of contrast-enhanced breast magnetic resonance imaging (CE-BMRI) vs X-ray mammography (XRM) to detect breast cancer.
Materials And Methods: We ran a supplemental analysis of 2 global Phase III studies which recruited patients with histologically proven breast cancers.
Background: PD-L1 receptor expression in breast cancer tissue can be assessed with different anti-human PD-L1 monoclonal antibodies. The performance of three specific monoclonal antibodies in a head-to-head comparison is unknown. In addition, a potential correlation of PD-L1 expression and clinico-pathological parameters has not been investigated.
View Article and Find Full Text PDFPurpose: The aim of this study was to analyze the risk of hypersensitivity reactions (HSRs) to iopromide in children and elderly patients in comparison to adults.
Materials And Methods: Four observational studies were pooled and analyzed (analysis I). In addition, spontaneous reports from 1985 to 2020 from the pharmacovigilance database were evaluated (analysis II).
Gadobutrol and gadoterate are widely used macrocyclic gadolinium-based contrast agents. Given gadobutrol's higher T1 relaxivity, a reduced gadobutrol dose should achieve essentially equivalent diagnostic efficacy as a standard dose of gadoterate. The purpose of our study was to show efficacy of a 25% reduced dose of gadobutrol is noninferior to 100% standard dose of gadoterate for contrast-enhanced MRI of the CNS.
View Article and Find Full Text PDFPurpose: To investigate whether a training program on breast ultrasound skills including core-needle biopsies to undergraduate students can improve medical knowledge and learning satisfaction.
Methods: Medical students attending mandatory classes at the Medical School of the University of Saarland received a supplemental theoretical and hands-on training program on ultrasound (US) breast screening and on US-guided core-needle biopsy using an agar-agar phantom. Experienced breast specialists and ultrasound examiners served as trainers applying Peyton's 4-step training approach.
Background: Detection of breast cancer in women with high breast densities is a clinical challenge.
Purpose: To study the influence of different degrees of breast density on the sensitivity of contrast-enhanced breast magnetic resonance imaging (CE-BMRI) versus X-ray mammography (XRM).
Material And Methods: We performed an additional analysis of two large Phase III clinical trials (G1; G2) which included women with histologically proven breast cancers, called "index cancers.
Background: Many factors influence the increase in signal intensity (SI) provided by magnetic resonance imaging (MRI) contrast media.
Purpose: To assess the impact of different gadolinium concentrations and dilutions of three macrocyclic gadolinium-based contrast agents (GBCA) on SI.
Material And Methods: This phantom study investigated gadobutrol, gadoteridol, and gadoterate in human plasma of a healthy donor pool at 37 °C.
Objective: To evaluate the prognostic potential of vimentin, p53, EGFR, CK5/6, CK 14, and CK 17 in patients with triple-negative breast cancer (TNBC).
Material And Methods: Tumor specimens of 60 patients with histologically confirmed TNBC were retrospectively analyzed. Formalin-fixed paraffin-embedded blocks of the tumor tissue were used to prepare tissue microarrays (TMAs).
Purpose: To compare the MEDRAD Stellant and MEDRAD Stellant FLEX computed tomography contrast media injection systems in terms of radiologic technologists' ability to visually identify air in the syringes at various distances and under different lighting conditions, as well as the ease of cleaning contrast media spills on the injector faces.
Methods: Ten experienced radiologic technologists performed 104 tests (52 per injector) in normal light and in ambient light conditions. The tests were randomized for the radiologic technologists' distance from the injector at 2 ft (61 cm), 8 ft (244 cm), and 16 ft (488 cm).
Objective: To assess the impact of piston-based peristaltic injection system technology and contrast media viscosity on achievable iodine delivery rates (IDRs) and vascular enhancement in a pre-clinical study.
Methods: Four injectors were tested: MEDRAD Centargo, MEDRAD Stellant, CT Exprès, and CT motion using five contrast media [iopromide (300 and 370 mgI ml), iodixanol 320 mgI ml, iohexol 350 mgI ml, iomeprol 400 mgI ml]. Three experiments were performed evaluating achievable IDR and corresponding enhancement in a circulation phantom.
Objective: To evaluate the potential impact of body mass index (BMI), smoking habit, alcohol consumption, physical activity and parity on disease course of women with triple-negative breast cancer (TNBC).
Material And Methods: This was a retrospective chart analysis of patients with TNBC. Primary target parameters were overall survival (OS) and disease-free survival (DFS) depending on BMI, smoking habit, alcohol consumption, physical activity and parity.
Objective: To compare the efficacy and safety of two post-operative drains in breast cancer patients after breast conserving surgery.
Methods: This was a prospectively randomized comparative study of two drains investigated in breast cancer patients after breast conserving therapy. The Redon drain ends in a tip with 28 double perforations while the Quadrain drain features 4 flexible flaps of about 0.
Objective: The aim of this study was to compare the risk of hypersensitivity reactions to iopromide after intra-arterial (IA) administration and intravenous (IV) administration.
Materials And Methods: Four observational studies were pooled. Almost half of the study population (48.
Purpose: The relaxivities of 3 macrocyclic gadolinium-based contrast agents (GBCAs) were determined in human plasma and blood under standardized and clinically relevant laboratory conditions.
Methods: The T1 relaxivity, r1, was determined in human plasma at 1.5, 3, and 7 T, and in human blood at 3 T at 37°C in phantoms containing 4 different concentrations of the macrocyclic GBCAs gadobutrol, gadoteridol, and gadoterate.
Purpose: To assess the change of body mass index (BMI), muscle mass, visceral and subcutaneous fat in patients with metastatic breast cancer.
Methods: In this retrospective chart analysis, patients with metastatic breast cancer as initial diagnosis between 2012 and 2016 were analyzed. Patients had received either chemotherapy (CTH) or endocrine therapy (ETH) according to the German S3 Guideline.
Purpose: To compare the fluid delivery performance of 2 different technologies for administration of iodinated contrast media in computed tomography (CT).
Methods: The maximum achievable flow rate and the steady-state flow rate variance of a piston-based contrast media injector system (Stellant MP, MEDRAD) was compared with peristaltic pump-based injector systems (CT motion, Ulrich Medical; CT Exprès, Bracco). The contrast media iopromide (Ultravist) and iopamidol (Isovue) were used at 2 concentrations each (300 and 370 mg I/mL) and 3 catheter sizes (18, 20, and 22 G) to test the injector performance.
Purpose: The aim of this study is to evaluate the diagnostic efficacy and safety of gadoxetate disodium vs gadobenate dimeglumine in patients with known or suspected focal liver lesions.
Methods: This was a prospective, multicenter, double-blind, randomized, inter-individual Phase III study. The primary target-technical efficacy-was already published.
Objective: To compare the country-specific value sets of the EQ-5D-5L utility index and to evaluate the impact on the interpretation of clinical study results. Six country value sets from Canada, England, Japan, Korea, Netherlands and Uruguay were obtained from literature. In addition, ten crosswalk value sets were downloaded from the EuroQol.
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