Inter- and intra-individual comparative study of two gadolinium-based agents: A pilot study

  • Shin, Kyung Sook; 
  • AlObaidy, Mamdoh; 
  • Ramalho, Miguel; 
  • Jeon, Yong Hwan; 
  • Burke, Lauren M.; 
  • 외 3명
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초록

The aim of the study was to evaluate the acute adverse events rate and enhancement properties of gadoterate meglumine (Dotarem(A (R))) and gadobenate dimeglumine (MultiHance(A (R))) in a small-scale controlled double-blinded study, using inter- and intra-individual comparisons. Forty-one randomly selected patients were scanned with Dotarem(A (R)). The rate of adverse reactions, qualitative and quantitative image evaluation was performed vs. a control group of 46 patients who underwent MultiHance(A (R)) over the same 1-month time period (population 1), and 27 patients who underwent both Dotarem(A (R)) and MultiHance(A (R))-enhanced body MRI studies within an 18-month period (population 2). Data were subjected to statistical analysis. Only 1 mild acute adverse event (vomiting) was observed in population 1 (with Dotarem(A (R))). Blinded assessment of image quality was good for both agents in all patients. Population 1 showed significantly higher liver percentage enhancement with MultiHance(A (R)) (p < 0.0001). There was a trend to higher pancreas-to-liver enhancement with Dotarem(A (R)), significant in population 2 (p = 0.0333). 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.

키워드

Gadolinium; Gadoterate meglumine; Gadobenate dimeglumine; Dotarem (R); MultiHance (R); Proof of concept; NEPHROGENIC SYSTEMIC FIBROSIS; CONTRAST-MEDIA REACTIONS; FOCAL LIVER-LESIONS; 1.0 M GADOBUTROL; PHASE-III TRIAL; GADOBENATE DIMEGLUMINE; GADOPENTETATE DIMEGLUMINE; DIAGNOSTIC-VALUE; CLINICAL SAFETY; DOUBLE-BLIND
제목
Inter- and intra-individual comparative study of two gadolinium-based agents: A pilot study
저자
Shin, Kyung Sook; AlObaidy, Mamdoh; Ramalho, Miguel; Jeon, Yong Hwan; Burke, Lauren M.; Altun, Ersan; Stallings, Clifton G.; Semelka, Richard C.
DOI
10.1007/s00261-014-0248-0
발행일
2015-04
유형
Article
저널명
Abdominal Imaging
권
40
호
4
페이지
865 ~ 874