CLINICAL TRIALS PROFILE FOR GADOTERATE MEGLUMINE
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All Clinical Trials for Gadoterate Meglumine
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00650845 ↗ | Renal Safety Evaluation After Dotarem®-Enhanced MRI | Completed | Guerbet | Phase 4 | 2008-01-01 | Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine. |
| NCT01010932 ↗ | Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) | Completed | Guerbet | Phase 3 | 2009-10-01 | The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. |
| NCT01012674 ↗ | Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) | Completed | Guerbet | Phase 3 | 2009-10-01 | The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. |
| NCT01254552 ↗ | Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis | Completed | Guerbet | Phase 4 | 2010-08-01 | The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA). |
| NCT01449266 ↗ | Safety and Dialysability of Dotarem® in Dialysed Patients | Completed | Guerbet | Phase 1 | 2011-11-01 | To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment. |
| NCT01806740 ↗ | DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC | Terminated | Guerbet | Phase 4 | 2013-05-09 | The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST. |
| NCT02411201 ↗ | DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years | Completed | Guerbet | Phase 4 | 2015-03-01 | The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®. DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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