Dataset Information

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).

ABSTRACT:

Objective

To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients.

Methods

Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 ?mol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 ± 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up.

Results

Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [? = -1.4 %, 95%CI = (-7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted.

Conclusion

Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD.

Key points

• Contrast-induced nephropathy (CIN) is a potential problem following gadolinium administration for MRI. • Meglumine gadoterate (Gd-DOTA) appears safe, even in patients with chronic kidney disease. • Gd-DOTA only caused a temporary creatinine level increase in 1/70 such patients. • No case or sign of NSF was detected at 3-month follow-up.

SUBMITTER: Deray G

PROVIDER: S-EPMC3622739 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).

Deray Gilbert G Rouviere Olivier O Bacigalupo Lorenzo L Maes Bart B Hannedouche Thierry T Vrtovsnik François F Rigothier Claire C Billiouw Jean-Marie JM Campioni Paolo P Ferreiros Joaquin J Devos Daniel D Alison Daniel D Glowacki François F Boffa Jean-Jacques JJ Marti-Bonmati Luis L

European radiology 20121205 5

<h4>Objective</h4>To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients.<h4>Methods</h4>Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A ...[more]

PMID: 23212275

Similar Datasets

Project description:OBJECTIVE:The objective of this study is to evaluate if intensified pre-scan patient preparation (IPPP) that comprises custom-made educational material on dynamic phase imaging and supervised pre-imaging breath-hold training in addition to standard informative conversation with verbal explanation of breath-hold commands (standard pre-scan patient preparation-SPPP) might reduce the incidence of gadoxetate disodium (Gd-EOB-DTPA)-related transient severe respiratory motion (TSM) and severity of respiratory motion (RM) during dynamic phase liver MRI. MATERIAL AND METHODS:In this bi-institutional study 100 and 110 patients who received Gd-EOB-DTPA for dynamic phase liver MRI were allocated to either IPPP or SPPP at site A and B. The control group comprised 202 patients who received gadoterate meglumine (Gd-DOTA) of which each 101 patients were allocated to IPPP or SPPP at site B. RM artefacts were scored retrospectively in dynamic phase images (1: none- 5: extensive) by five and two blinded readers at site A and B, respectively, and in the hepatobiliary phase of the Gd-EOB-DTPA-enhanced scans by two blinded readers at either site. RESULTS:The incidence of TSM was 15% at site A and 22.7% at site B (p = 0.157). IPPP did not reduce the incidence of TSM in comparison to SPPP: 16.7% vs. 21.6% (p = 0.366). This finding was consistent at site A: 12% vs. 18% (p = 0.401) and site B: 20.6% vs. 25% (p = 0.590). The TSM incidence in patients with IPPP and SPPP did not differ significantly between both sites (p = 0.227; p = 0.390). IPPP did not significantly mitigate RM in comparison to SPPP in any of the Gd-EOB-DTPA-enhanced dynamic phases and the hepatobiliary phase in patients without TSM (all p≥0.072). In the Gd-DOTA control group on the other hand, IPPP significantly mitigated RM in all dynamic phases in comparison to SPPP (all p≤0.031). CONCLUSIONS:We conclude that Gd-EOB-DTPA-related TSM cannot be mitigated by education and training and that Gd-EOB-DTPA-related breath-hold difficulty does not only affect the subgroup of patients with TSM or exclusively the arterial phase as previously proposed.

Project description:ObjectivesThe primary objective of this study was to investigate the pharmacokinetic profile of gadoterate meglumine in pediatric patients younger than 2 years; the secondary objectives were to document its efficacy and safety.Material and methodsThis was a Phase IV open-label, prospective study conducted in 9 centers (4 countries). Forty-five patients younger than 2 years with normal estimated glomerular filtration rate and scheduled to undergo routine gadolinium-enhanced magnetic resonance imaging (MRI) of any organ were included and received a single intravenous injection of gadoterate meglumine (0.1 mmol/kg). To perform the population pharmacokinetics analysis, 3 blood samples per subject were drawn during 3 time windows at time points allocated by randomization.ResultsGadoterate meglumine concentrations were best fitted using a 2-compartmental model with linear elimination from central compartment. The median total clearance adjusted to body weight was estimated at 0.06 L/h per kg and increased with estimated glomerular filtration rate according to a power model. The median volume of distribution at steady state (Vss) adjusted to body weight was estimated at 0.047 L/kg. Estimated median terminal half-life (t1/2β) was 1.35 h, and the median systemic exposure (area under the curve) was 1591 μmol h/L. Efficacy was assessed by comparing precontrast +postcontrast images to precontrast images in a subset of 28 subjects who underwent an MRI examination of brain, spine, and associated tissues. A total of 28 lesions were identified and analyzed in 15 subjects with precontrast images versus 30 lesions in 16 subjects with precontrast + postcontrast images. Lesion visualization was improved with a mean (SD) increase in scores at subject level of 0.7 (1.0) for lesion border delineation, 0.9 (1.6) for internal morphology, and 3.1 (3.2) for contrast enhancement. Twenty-six adverse events occurred postinjection in 13 subjects (28.9%), including 3 serious reported in 1 subject (2.2%). One subject (2.2%) experienced 1 rash of moderate intensity considered as related to gadoterate meglumine.ConclusionsThe pharmacokinetic profile of gadoterate meglumine after a single intravenous injection of 0.1 mmol/kg was appropriately described in newborns and infants younger than 2 years, for whom no dose adjustment is required. The improved efficacy of gadoterate meglumine for contrast-enhanced MRI examination of brain, spine, and associated tissues, as well as its good safety profile, was also demonstrated in this population.

Dataset Information

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).

Objective

Methods

Results

Conclusion

Key points

Publications

Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets