ArticlePediatric radiology2016
Safety of gadobutrol in more than 1,000 pediatric patients: subanalysis of the GARDIAN study, a global multicenter prospective non-interventional study.
Article in Pediatric radiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents: A Systematic Review.Annals of internal medicine · 2020Pooled it
- Safety of Gadobutrol: Results From 42 Clinical Phase II to IV Studies and Postmarketing Surveillance After 29 Million Applications.Investigative radiology · 2016Trial
- Comparison Between Visual Assessment and Apparent Diffusion Coefficient (ADC) Value Measurement on Diffusion Weighted Imaging (DWI) in Supratentorial Glioma Grading in Children.Medical archives (Sarajevo, Bosnia and Herzegovina) · 2025Article
- Sentinel Lymph Node Detection in Early-Stage Oral Squamous Cell Carcinoma Using Magnetic Resonance Lymphography: A Pilot Study.Journal of clinical medicine · 2024Article
- Safety considerations related to intravenous contrast agents in pediatric imaging.Pediatric radiology · 2023Review
- Effects of chemical forms of gadolinium on the spleen in mice after single intravenous administration.Biochemistry and biophysics reports · 2022Article
- Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients.Journal of magnetic resonance imaging : JMRI · 2020Article
- Safety of gadoterate meglumine in over 1600 children included in the prospective observational SECURE study.Acta radiologica (Stockholm, Sweden : 1987) · 2019Observational
- Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children.Acta radiologica (Stockholm, Sweden : 1987) · 2019Article
- Practical administration of intravenous contrast media in children: screening, prophylaxis, administration and treatment of adverse reactions.Pediatric radiology · 2019Review
- Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan.Japanese journal of radiology · 2018Article
- Gadobutrol: A Review in Contrast-Enhanced MRI and MRA.Clinical drug investigation · 2018Review
- Gadolinium-Based Contrast Agents in Kidney Disease: A Comprehensive Review and Clinical Practice Guideline Issued by the Canadian Association of Radiologists.Canadian journal of kidney health and disease · 2018Article
- Pediatric brain MRI part 1: basic techniques.Pediatric radiology · 2017Review
- Gadobutrol in India-A Comprehensive Review of Safety and Efficacy.Magnetic resonance insights · 2017Review
Corrections and comments
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Authors and funding
10 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGadobutrol 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.
objectiveThis subanalysis of data from the GARDIAN study evaluated the safety and use of gadobutrol in pediatric patients (age <18 years). MATERIALS AND
methodsThe 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.
resultsThe 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.
conclusionGadobutrol 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.
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