N/A N=35,921 Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
General Safety Profile of DOTAREM
Primary: Frequency of Adverse Events — 70 Adverse Events
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 4 N=132 Renal Safety Evaluation After Dotarem®-Enhanced MRI
Renal Insufficiency
Primary: Number of Patients Presenting Contrast-induced Nephropathy as Defined by an Increase in Serum Creatinine Levels of a Least 25% Over Baseline Levels, in the Full Analysis…
Phase 3 N=402 Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Diagnostic Self Evaluation · Central Nervous System Diseases
Primary: MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation — 1.06; 3.30; 1.62…
N/A N=44,456 Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Contrast-enhanced MRI With Dotarem
Primary: Frequency of Adverse Events — 225 adverse events
Phase 1 N=10 Safety and Dialysability of Dotarem® in Dialysed Patients
End-stage Renal Failure
Primary: Dialysability of Dotarem® in Dialysed Patients — -88.2; -93.4; -97.1; -94.8 percent change in Gd concentration
Phase 4 N=51 DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
Magnetic Resonance Imaging
Primary: Area Under the Curve of DOTAREM in Plasma — 1591.1 hour.µmol/L
N/A N=1,537 Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
MR Mammography With Dotarem
Primary: Image Quality — 495; 898; 118; 8 Participants
Phase 4 N=20 DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
Peripheral Arterial Disease
Primary: Overall Image Quality of MRA Images — 56; 48 Images
N/A N=540 Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
Renal Insufficiency
Primary: Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem — 0 Participants
Phase 4 N=157 Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Magnetic Resonance Imaging
Primary: Degree of Lesion Contrast Enhancement — 0.884; 0.863; 3.007; 2.979 Scores on a scale — p=< 0.0001
Phase 4 N=268 Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
Primary Brain Tumor
Primary: Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent — 94.0; 96.2; 93.2; 90.6 percentage of patients
Phase 3 N=211 Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Cerebral Arterial Diseases
Primary: Technical Failure Rate — 3.55; 29.22; 1.57; 17.65 percentage of arterial segments
Phase 3 N=222 Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Cerebral Arterial Diseases
Primary: Technical Failure Rate — 4.65; 29.44; 1.77; 16.70 percentage of arterial segments
Phase 4 N=186 Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
Peripheral Arterial Disease
Primary: Intra-patient Accuracy (Percent Agreement), On-site Data — 77.1; 80.6 percentage of agreement
Phase 4 N=177 Crossover Comparison of MultiHance and Dotarem
Brain Disease
Primary: Global Diagnostic Preference Between the Two Exams — 31; 51; 43; 14 participant exams — p=<0.0001
Phase 4 N=169 Isovue in Peripheral Digital Subtraction Angiography (DSA)
Peripheral Arterial Occlusive Disease
Primary: Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or…
Phase 4 N=44 Eovist vs. Dotarem Healthy Volunteer MRI
Transient Severe Arterial Phase Motion
Primary: Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath — 28; 38; 35 seconds
Phase 2 N=284 Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
Chronic Renal Insufficiency · Diabete Mellitus · Congestive Heart Failure
Primary: Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. — 65; 71; 57; 59 Number of subjects
Phase 2 N=50 Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
Healthy
Primary: Blood Urea Nitrogen and Creatinine Serum Values — 12.3; 14.7; 14.5; 12.8 mg/dL
Phase 4 N=1,060 A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
Cardiovascular Disease
Primary: The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration — 0 Participants
Phase 3 N=256 Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
CNS Lesion · Blood Brain Barrier Defect
Primary: Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI — 3.90; 2.08; 3.64; 1.74 mean of a score (on a scale) per patient — p=<.0001
Phase 2 N=280 P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
CNS Lesion · Blood Brain Barrier Defect
Primary: Contrast to Noise Ratio (CNR) Difference — -10.59; 2.18; 8.66; 14.45 Ratio — p=0.1858
Phase 3 N=165 SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study
Brain Metastases
Primary: Number of Lesions Detected by Blinded Readers (BR) and Investigator — 6.28; 6.92; 6.87; 6.36 lesions
Phase 3 N=434 Ultravist: Safety and Efficacy in Computed Tomography of Head and Body
Computed Tomography · Diagnostic Imaging
Primary: The Quality of Visualization of the Contrast-Enhanced Computed Tomography (CECT) Images, Based on the Blinded Readers' Assessment. — 366; 17; 16; 3 Number of…
Phase 2 N=36 Safety of SonoVue on Pulmonary Hemodynamics
Pulmonary Hypertension
Primary: Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline — 50.50; 50.50; 30.08; 30.08 mmHg
Phase 4 N=213 Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Chronic Kidney Disease · Renal Insufficiency
Primary: Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in…
Phase 3 N=402 Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
Diagnostic Imaging · Central Nervous System Diseases
Primary: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic…
Phase 3 N=304 Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Lesion in Body Region
Primary: Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI — 3.79; 2.26; 3.48; 3.01 mean of a score (on a scale) per patient — p=< 0.0001
Phase 3 N=343 Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging
Central Nervous System Diseases
Primary: Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic…
N/A N=513 Comparison of Contrast Agents During CT Angiography
Contrast Enhancement on Cardiac CT
Primary: Image Quality of the CT Scans Using Different Contrast Agents — 333; 357; 362; 288 hounsfield units