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

Abstract

ObjectiveTo 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.MethodsPatients 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 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.ResultsAmong 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 [Δ = −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.ConclusionMeglumine 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.

Functional imaging of the human placenta with magnetic resonance

“…52 Second, gadolinium chelates should not be used routinely in pregnant women. Although no teratogenic or detrimental effects have been reported in animal studies, 9,[15][16][17]65,66 the challenge to clinical practice is the safety of transplacental passage of gadolinium-based contrast agents in the fetus, which has left many basic questions that are related to placental and fetal physiologic condition unexplored to date. 67 Gadolinium chelates may be used in pregnancy, in limited situations when the benefits outweigh the potential risks, for example in cases of suspected placenta accreta.…”

Renal safety of intravenous gadolinium‐enhanced magnetic resonance imaging in patients awaiting liver transplantation

“…Our study had an average follow-up period for NSF of 25.8 months, and this follow-up duration is similar to previous studies that have monitored for NSF over a period of several months. 31 However, longer follow-up periods may be required to monitor for NSF given gadolinium's tissue residence of 4 to 11 months. 15 Though the sample size of this study is large enough to substantiate its results, its retrospective design without a control group comparison is a potential weakness.…”

Nanomedicine in diagnostics and therapy of cardiovascular diseases: beyond atherosclerotic plaque imaging

“…Within the last 3 years, two new molecular MRI agents have been approved for clinical use, exhibiting excellent safety profiles [104] . A recent report from the RESCUE study showed that gadolinium-DOTA did not affect the renal function and was a safe contrast agent in the patients with chronic kidney disease [105] . It must be noted, however, that even in the case of the targeted nanoparticles, most of the applied dose accumulates in the liver, spleen, kidneys and bladder.…”