Relationship of Dose and Signal Enhancement Properties of Gadoquatrane, a New Tetrameric, Macrocyclic Gadolinium-Based Contrast Agent, Compared With Gadobutrol: A Randomized Crossover Study in Healthy Adults.

Objectives: To investigate the signal-enhancement properties of the tetrameric gadolinium-based contrast agent (GBCA) gadoquatrane in relation to the administered dose and compare its properties to those of a standard dose of gadobutrol, as a representative of the currently established macrocyclic GBCAs for magnetic resonance imaging.

Materials And Methods: In this randomized, single-blind, 4 × 4 crossover study, 43 healthy adults (19-50 years of age) received 3 single IV injections of gadoquatrane (0.01, 0.

Developments in X-Ray Contrast Media and the Potential Impact on Computed Tomography.

Over the past 120 years, continuous developments in medical imaging has improved diagnosis and treatment for many diseases and has thereby improved treatment outcome and quality of life of many patients. The number of computed tomography (CT) examinations is today increasing by 4% per year worldwide, for a total of approximately 300 million CT scans per year. About 40% of CT scans are contrast enhanced.

Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States.

Background: Although it is generally acknowledged that exposure to iodine contrast agents can interfere with thyroid function, little is known about the incidence of iodine-induced hypothyroidism in young children (younger than the age of 4 years).

Study Objectives: This was a retrospective cohort study to estimate the incidence rate of detected hypothyroidism in a US-based general population of pediatric patients exposed to an iodinated contrast agent.

Setting: The study was conducted in Kaiser Permanente Northern California, an integrated health care delivery system.

Hypothyroidism in Young Children Following Exposure to Iodinated Contrast Media: An Observational Study and a Review of the Literature.

While it is well documented that exposure to iodinated contrast media (ICM) can interfere with thyroid function in adults, much less is known about the incidence and risk factors associated with ICM induced hypothyroidism in young children. Using a computerized database we identified 843 children who were exposed to ICM between 1998 and 2015. The incidence rate of ICM induced hypothyroidism per 1000 person-years was 9.

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.

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study.

Objectives: To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.

Methods: GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events.

Results: Median gadobutrol dose was 0.

Safety of gadopentetate dimeglumine after 120 million administrations over 25 years of clinical use.

Purpose: We evaluated the safety of gadopentetate dimeglumine (Gd-DTPA), the first contrast agent for magnetic resonance imaging, using pharmacovigilance data for spontaneously reported adverse events (AEs) after 120 million cumulative administrations worldwide.

Methods: We analyzed spontaneously reported AEs for Gd-DTPA for pre-specified time periods between 1988 and 2011.

Results: Since the market introduction of Gd-DTPA in 1988, its global utilization reached 120 million cumulative administrations in 2011, more than 80% of which was by the USA, countries in the European Union (EU), and Japan.

Safety and tolerability of iopromide intravascular use: a pooled analysis of three non-interventional studies in 132,012 patients.

Background: Determining the safety of contrast agents is challenging. In the absence of large controlled clinical trials, non-interventional (post-marketing surveillance) studies provide an opportunity to clearly investigate the safety profile of contrast agents.

Purpose: To assess the safety profile of iopromide in contrast-enhanced X-ray in clinical practice, using pooled data from three non-interventional studies.

Safety and diagnostic image quality of iopromide: results of a large non-interventional observational study of European and Asian patients (IMAGE).

Background: Iodine-based contrast agents such as iopromide play a central role in improving the diagnostic quality of imaging modalities using ionizing radiation.

Purpose: To investigate the safety and diagnostic image quality of iopromide in the routine clinical setting.

Material And Methods: This was an international, multicenter, prospective, single-arm, non-interventional study (NIS).

Evaluation of the effect of two gadolinium-containing contrast-enhancing agents, gadobutrol and gadoxetate disodium, on colorimetric calcium determinations in serum and plasma.

Objective: To determine the extent to which the gadolinium-containing contrast agents, gadobutrol (Gadovist) and gadoxetate disodium (Primovist/Eovist), interfere with the colorimetric measurement of calcium concentrations in serum and plasma.

Materials And Methods: Gadobutrol and gadoxetate disodium were added in various concentrations to serum and plasma from healthy volunteers; the calcium concentration in these samples was then measured by standard colorimetry methods and atomic absorption.

Results: At clinically relevant concentrations, neither gadobutrol nor gadoxetate disodium influenced the results of the calcium measurement in serum or plasma.

Prevalence of acute adverse reactions to gadobutrol--a highly concentrated macrocyclic gadolinium chelate: review of 14,299 patients from observational trials.

Objective: To determine the safety and tolerability of gadobutrol in a large number of non-selected patients from routine clinical radiology practices.

Materials And Methods: Six prospectively planned, observational surveillance studies were conducted at more than 300 institutions in Europe and Canada from 2000 to 2007. Demographic and medical status data, details of the diagnostic procedure, contrast agent administration and adverse drug reaction (ADR) data were collected using a standardized questionnaire.