ABSTRACT
PURPOSE: The aim of the study was to evaluate the acute adverse events rate and enhancement properties of gadoterate meglumine (Dotarem(®)) and gadobenate dimeglumine (MultiHance(®)) in a small-scale controlled double-blinded study, using inter- and intra-individual comparisons. MATERIALS AND METHODS: Forty-one randomly selected patients were scanned with Dotarem(®). The rate of adverse reactions, qualitative and quantitative image evaluation was performed vs. a control group of 46 patients who underwent MultiHance(®) over the same 1-month time period (population 1), and 27 patients who underwent both Dotarem(®) and MultiHance(®)-enhanced body MRI studies within an 18-month period (population 2). Data were subjected to statistical analysis. RESULTS: Only 1 mild acute adverse event (vomiting) was observed in population 1 (with Dotarem(®)). Blinded assessment of image quality was good for both agents in all patients. Population 1 showed significantly higher liver percentage enhancement with MultiHance(®) (p < 0.0001). There was a trend to higher pancreas-to-liver enhancement with Dotarem(®), significant in population 2 (p = 0.0333). CONCLUSION: This small-scale multi-blinded study characterizes a strategy to objectively assess intravenous contrast agents, which may be an ideal method to evaluate whether a new contrast agent should be introduced for clinical use at any institution, and to re-evaluate the agent in standard use. Whenever available, intra-individual assessment may be ideal.
Subject(s)
Image Enhancement/methods , Magnetic Resonance Imaging , Meglumine/analogs & derivatives , Organometallic Compounds/administration & dosage , Organometallic Compounds/adverse effects , Aorta/anatomy & histology , Contrast Media/administration & dosage , Contrast Media/adverse effects , Double-Blind Method , Feasibility Studies , Female , Humans , Imaging, Three-Dimensional , Liver/anatomy & histology , Male , Meglumine/administration & dosage , Meglumine/adverse effects , Middle Aged , Observer Variation , Pancreas/anatomy & histology , Pilot Projects , Reproducibility of Results , Sensitivity and Specificity , Vomiting/chemically inducedABSTRACT
PURPOSE: The purpose was to objectively evaluate a recently FDA-approved gadolinium-based contrast agent (GBCA) in comparison to our standard GBCA for acute adverse events and image quality by blinded evaluation. METHODS: Evaluation was made of a recently FDA-approved GBCA, gadobutrol (Gadavist; Bayer), in comparison to our standard GBCA, gadobenate dimeglumine (MultiHance; Bracco), in an IRB- and HIPAA-compliant study. Both the imaging technologist and patient were not aware of the brand of the GBCA used. A total of 59 magnetic resonance studies were evaluated (59 patients, 31 men, 28 women, age range of 5-85 years, mean age of 52 years). Twenty-nine studies were performed with gadobutrol (22 abdominal and 7 brain studies), and 30 studies were performed with gadobenate dimeglumine (22 abdominal and 8 brain studies). Assessment was made of acute adverse events focusing on objective observations of vomiting, hives, and moderate and severe reactions. Adequacy of enhancement was rated as poor, fair and good by one of two experienced radiologists who were blinded to the type of agent evaluated. RESULTS: No patient experienced acute adverse events with either agent. The target minor adverse events of vomiting or hives, and moderate and severe reactions were not observed in any patient. Adequacy of enhancement was rated as good for both agents in all patients. CONCLUSIONS: Objective, blinded evaluation is feasible and readily performable for the evaluation of GBCAs. This proof-of-concept study showed that both GBCAs evaluated exhibited consistent good image quality and no noteworthy adverse events.
Subject(s)
Drug Eruptions/etiology , Magnetic Resonance Imaging/adverse effects , Meglumine/analogs & derivatives , Organometallic Compounds/adverse effects , Vomiting/chemically induced , Adolescent , Adult , Aged , Aged, 80 and over , Child, Preschool , Contrast Media/adverse effects , Drug Eruptions/diagnosis , Female , Humans , Male , Meglumine/adverse effects , Middle Aged , Pilot Projects , Reproducibility of Results , Sensitivity and Specificity , Single-Blind Method , Vomiting/diagnosis , Young AdultABSTRACT
OBJECTIVE: To evaluate a comprehensive MRI protocol that investigates for cancer, vascular disease, and degenerative/inflammatory disease from the head to the pelvis in less than 40 minutes on a new generation 48-channel 3T system. MATERIALS AND METHODS: All MR studies were performed on a 48-channel 3T MR scanner. A 20-channel head/neck coil, two 18-channel body arrays, and a 32-channel spine array were employed. A total of 4 healthy individuals were studied. The designed protocol included a combination of single-shot T2-weighted sequences, T1-weighted 3D gradient-echo pre- and post-gadolinium. All images were retrospectively evaluated by two radiologists independently for overall image quality. RESULTS: The image quality for cancer was rated as excellent in the liver, pancreas, kidneys, lungs, pelvic organs, and brain, and rated as fair in the colon and breast. For vascular diseases ratings were excellent in the aorta, major branch vessel origins, inferior vena cava, portal and hepatic veins, rated as good in pulmonary arteries, and as poor in the coronary arteries. For degenerative/inflammatory diseases ratings were excellent in the brain, liver and pancreas. The inter-observer agreement was excellent. CONCLUSION: A comprehensive and time efficient screening for important categories of disease processes may be achieved with high quality imaging in a new generation 48-channel 3T system.
OBJETIVO: Avaliar protocolo de RM para investigação de neoplasia, doenças vascular e degenerativa/inflamatória da cabeça à pelve em menos de 40 minutos em equipamento 3T com 48 canais. MATERIAIS E MÉTODOS: Todos os exames foram realizados em equipamento 3T com 48 canais. Foram utilizadas bobinas de cabeça/pescoço (20 canais), duas de corpo interligadas (18 canais) e uma de coluna (32 canais). Quatro voluntários saudáveis foram estudados. Foi utilizado protocolo com sequências single shot pesadas em T2 e gradiente-eco 3D pesadas em T1 pré e pós-gadolínio. Todas as imagens foram avaliadas quanto à qualidade, retrospectivamente, por dois radiologistas de forma independente. RESULTADOS: A qualidade da imagem foi classificada como excelente para o fígado, pâncreas, rins, pulmões, órgãos pélvicos e encéfalo, e como adequada para cólon e mamas. Para as doenças vasculares as imagens foram classificadas como excelentes para aorta e seus ramos principais, veia cava inferior, veias porta e hepáticas, como boas para artérias pulmonares, e como inadequadas para coronárias. As classificações para doenças degenerativas/inflamatórias foram excelente no encéfalo, fígado e pâncreas. A concordância interobservador foi excelente. CONCLUSÃO: Um rastreamento abrangente de importantes categorias de doenças pode ser realizado utilizando imagens de alta qualidade obtidas em uma nova geração de equipamento 3T com 48 canais.
