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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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
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 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=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…
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
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
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=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=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
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 3 N=315 Gadobutrol Enhanced MRA of the Renal Arteries
Renal Artery Obstruction
Primary: Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA — 95.9; 77.6; 98.1; 81.7 Percentage of segments — p=<0.000
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=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 3 N=479 Gadobutrol Enhanced MRA of the Supra-aortic Vessels
Carotid Stenosis
Primary: Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA — 95.0; 72.7; 88.2; 24.4 percentage of segments — p=<0.0001
N/A N=2,978 Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
Breast Carcinoma
Primary: Rate of Detection of Invasive Cancers — 9; 14 Participants
Phase 3 N=446 Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
Breast Cancer · Diagnostic Imaging
Primary: Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader — 46.6; 30.8; 23.3; 17.8 difference in sensitivity (%)
N/A N=298 Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Breast Biopsy
Primary: Impact of US-guided DOT on the Potential Reduction of Benign Biopsies as Measured by Comparing the Reads With a Non- Suspicious Assessment of Conventional Imaging (CI)…
Phase 4 N=615 Screening Contrast-Enhanced Mammography as an Alternative to MRI
Breast Cancer
Primary: Cancer Detection Rate (CDR) Per 1,000 Screenings — 8.3; 18.3 CDR per 1,000 screenings
N/A N=128 Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
Breast Cancer
Primary: Percent Accuracy of Contrast Mammography — 100; 67 percentage of accuracy
Phase 2 N=191 Coronary MDCTA With Iopamidol Injection 370
Coronary Artery Disease
Primary: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 — 949; 842; 841 Segments Visualized Accurately — p=0.0099
Phase 2 N=232 Myocardial Perfusion MRI
Myocardial Perfusion Imaging · Magnetic Resonance Imaging
Primary: Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of…
N/A N=72 The Prone to Supine Breast MRI Trial
Breast Cancer
Primary: Number of Successful Segmentation of Supine MRI Images — 54; 61 Participants
Phase 3 N=460 Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI)
Breast Cancer
Primary: Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader — 15.2; 31.9; 30.4; 15.9 difference in sensitivity (%)
N/A N=66 Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
Solitary Pulmonary Nodules
Primary: Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest — 3.4540 units on a scale
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
N/A N=24 Image Quality Assessment for Screening and Diagnostic Mammography
Breast Health
Primary: Number of Participants With Acceptable Overall Clinical Image Quality — 14; 9 Participants