Trial reportInvestigative radiology2015
Nephrogenic systemic fibrosis risk after liver magnetic resonance imaging with gadoxetate disodium in patients with moderate to severe renal impairment: results of a prospective, open-label, multicenter study.
Trial report in Investigative radiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents: A Systematic Review.Annals of internal medicine · 2020Pooled it
- Gadobutrol in Renally Impaired Patients: Results of the GRIP Study.Investigative radiology · 2017Trial
- Clinical Safety of Gadoxetate Disodium: Insights From 20 Years of Use and More Than 12 Million Administrations.Investigative radiology · 2026Article
- Safety of a Tailored Gadolinium-Based Contrast Agent Protocol Considering Excretion Pathways in Patients with Renal Impairment.Diagnostics (Basel, Switzerland) · 2026Article
- Abbreviated MRI with second shot arterial phase for HCC evaluation: modified version of LI-RADS and recall reduction strategy.European radiology · 2023Article
- Gadolinium-Based Contrast Agents: Updates and Answers to Typical Questions Regarding Gadolinium Use.Texas Heart Institute journal · 2022Review
- Risk of nephrogenic systemic fibrosis in patients with impaired renal function undergoing fixed-dose gadoxetic acid-enhanced magnetic resonance imaging.Abdominal radiology (New York) · 2021Article
- Paediatric gastrointestinal and hepatobiliary radiology: why do we need subspecialists, and what is new?Pediatric radiology · 2021Review
- Superparamagnetic iron oxide-enhanced MRI-guided stereotactic ablative radiation therapy for liver metastasis.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2021Article
- Tissue-tracking in the assessment of late gadolinium enhancement in myocarditis and myocardial infarction.Magnetic resonance imaging · 2020Article
- Abbreviated Gadoxetic Acid-enhanced MRI with Second-Shot Arterial Phase Imaging for Liver Metastasis Evaluation.Radiology. Imaging cancer · 2019Article
- Intravenous gadolinium-based hepatocyte-specific contrast agents (HSCAs) for contrast-enhanced liver magnetic resonance imaging in pediatric patients: what the radiologist should know.Pediatric radiology · 2019Review
- Second shot arterial phase to overcome degraded hepatic arterial phase in liver 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
- Diagnostic Efficacy and Safety of Gadoxetate Disodium vs Gadobenate Dimeglumine in Patients With Known or Suspected Focal Liver Lesions: Results of a Clinical Phase III Study.Magnetic resonance insights · 2019Article
- 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
- Article
- 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
- Gadolinium-based contrast agents in pediatric magnetic resonance imaging.Pediatric radiology · 2017Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe objective of this study was to assess the risk of gadoxetate disodium in liver imaging for the development of nephrogenic systemic fibrosis (NSF) in patients with moderate to severe renal impairment. MATERIALS AND
methodsWe performed a prospective, multicenter, nonrandomized, open-label phase 4 study in 35 centers from May 2009 to July 2013. The study population consisted of patients with moderate to severe renal impairment scheduled for liver imaging with gadoxetate disodium. All patients received a single intravenous bolus injection of 0.025-mmol/kg body weight of liver-specific gadoxetate disodium. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.
resultsA total of 357 patients were included, with 85 patients with severe and 193 patients with moderate renal impairment, which were the clinically most relevant groups. The mean time period from diagnosis of renal disease to liver magnetic resonance imaging (MRI) was 1.53 and 5.46 years in the moderate and severe renal impairment cohort, respectively. Overall, 101 patients (28%) underwent additional contrast-enhanced MRI with other gadolinium-based MRI contrast agents within 12 months before the start of the study or in the follow-up. No patient developed symptoms conclusive of NSF within the 2-year follow-up.
conclusionsGadoxetate disodium in patients with moderate to severe renal impairment did not raise any clinically significant safety concern. No NSF cases were observed.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.