Observational studyJournal of magnetic resonance imaging : JMRI2017
Observational study on the safety profile of gadoterate meglumine in 35,499 patients: The SECURE study.
Observational study in Journal of magnetic resonance imaging : JMRI, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents: A Systematic Review.Annals of internal medicine · 2020Pooled it
- Risk of Nephrogenic Systemic Fibrosis in Patients With Stage 4 or 5 Chronic Kidney Disease Receiving a Group II Gadolinium-Based Contrast Agent: A Systematic Review and Meta-analysis.JAMA internal medicine · 2020Pooled it
- Prone-to-Supine Breast MRI for Tumor Margin Visibility and Surgical Guidance.Journal of breast imaging · 2026Article
- Review
- Feasibility and safety of contrast-enhanced magnetic resonance-guided adaptive radiotherapy for upper abdominal tumors: A preliminary exploration.Physics and imaging in radiation oncology · 2024Article
- Nephrogenic Systemic Fibrosis in Patients with Chronic Kidney Disease after the Use of Gadolinium-Based Contrast Agents: A Review for the Cardiovascular Imager.Diagnostics (Basel, Switzerland) · 2022Review
- Article
- Investigation of the Characteristics of New, Uniform, Extremely Small Iron-Based Nanoparticles as T1 Contrast Agents for MRI.Korean journal of radiology · 2021Article
- Nephrogenic systemic fibrosis: A frivolous entity.World journal of nephrology · 2021Review
- Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study.BMC medical imaging · 2021Observational
- The Pattern of Use, Effectiveness, and Safety of Gadoteric Acid (Clariscan) in Patients Undergoing Contrast-Enhanced Magnetic Resonance Imaging: A Prospective, Multicenter, Observational Study.Contrast media & molecular imaging · 2021Observational
- Decreased native renal TJournal of magnetic resonance imaging : JMRI · 2020Article
- Prospective Multicenter Study of the Safety of Gadoteridol in 6163 Patients.Journal of magnetic resonance imaging : JMRI · 2020Article
- Abbreviated MRI protocol for colorectal liver metastases: How the radiologist could work in pre surgical setting.PloS one · 2020Article
- Safety of gadoterate meglumine in over 1600 children included in the prospective observational SECURE study.Acta radiologica (Stockholm, Sweden : 1987) · 2019Observational
- Preoperative evaluation of small bowel complications in Crohn's disease: comparison of diffusion-weighted and contrast-enhanced MR imaging.European radiology · 2019Article
- Absence of potential gadolinium toxicity symptoms following 22,897 gadoteric acid (Dotarem®) examinations, including 3,209 performed on renally insufficient individuals.European radiology · 2019Observational
- Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan.Japanese journal of radiology · 2018Article
- Half-dose versus full-dose macrocyclic gadolinium at 3-T magnetic resonance imaging in paediatric bone and soft-tissue disease.Pediatric radiology · 2018Article
- 10 Years of Nephrogenic Systemic Fibrosis: A Comprehensive Analysis of Nephrogenic Systemic Fibrosis Reports Received by a Pharmaceutical Company from 2006 to 2016.Investigative radiology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo investigate the safety of gadoterate meglumine and identify the incidence of nephrogenic systemic fibrosis (NSF). MATERIALS AND
methodsAn international prospective observational study was conducted from November 2008 to June 2013. A total of 35,499 adults and children who were scheduled to undergo contrast-enhanced MRI using gadoterate meglumine were analyzed (female, 53.1%; mean age: 49.5 years; range: 0-98 years). At least 3-month follow-up was planned for patients with an estimated creatinine clearance or glomerular filtration rate <60 mL/min (/1.73 m2) to detect any suspicion or occurrence of NSF. Adverse events (AEs) were prospectively recorded. Demographic data, risk factors, indications for MRI examinations, characteristics of gadoterate meglumine administration, and efficacy were documented.
resultsMRI examinations were mainly for central nervous system (61%). The most frequent risk factor was renal insufficiency (14.7%). Seventy AEs were observed in 44 patients (0.12%). Among the 70 AEs, 38 in 32 patients (0.09% of all patients) were considered related to gadoterate meglumine and classified as adverse drug reaction (ADR).The most frequent ADRs were urticaria (9 patients, 0.03%), nausea (7 patients, 0.02%), and vomiting (4 patients, 0.01%). Within the pediatric population (1,629 patients), only one AE (vomiting) was observed. Nine adult patients (0.03%) experienced serious AEs. Moderate to severe renal insufficiency at inclusion was reported in 514 patients (1.5%). Among them, 476 (92.6%) were followed-up. No patients were suspected of having NSF and no cases of NSF were observed.
conclusionOur study confirms the excellent safety profile of gadoterate meglumine in routine practice. LEVEL OF EVIDENCE: 1 J. Magn. Reson. Imaging 2017;45:988-997.
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