30 closest matches · ranked by relevance
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…
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
Peripheral Arterial Disease
Primary: Overall Image Quality of MRA Images — 56; 48 Images
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…
Peripheral Arterial Disease
Primary: Intra-patient Accuracy (Percent Agreement), On-site Data — 77.1; 80.6 percentage of agreement
Brain Disease
Primary: Global Diagnostic Preference Between the Two Exams — 31; 51; 43; 14 participant exams — p=<0.0001
Contrast-enhanced MRI With Dotarem
Primary: Frequency of Adverse Events — 225 adverse events
Cerebral Arterial Diseases
Primary: Technical Failure Rate — 3.55; 29.22; 1.57; 17.65 percentage of arterial segments
Cerebral Arterial Diseases
Primary: Technical Failure Rate — 4.65; 29.44; 1.77; 16.70 percentage of arterial segments
Magnetic Resonance Imaging
Primary: Degree of Lesion Contrast Enhancement — 0.884; 0.863; 3.007; 2.979 Scores on a scale — p=< 0.0001
MR Mammography With Dotarem
Primary: Image Quality — 495; 898; 118; 8 Participants
General Safety Profile of DOTAREM
Primary: Frequency of Adverse Events — 70 Adverse Events
End-stage Renal Failure
Primary: Dialysability of Dotarem® in Dialysed Patients — -88.2; -93.4; -97.1; -94.8 percent change in Gd concentration
Magnetic Resonance Imaging
Primary: Area Under the Curve of DOTAREM in Plasma — 1591.1 hour.µmol/L
Renal Insufficiency
Primary: Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem — 0 Participants
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
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
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
Brain Tumor
Primary: Global Diagnostic Preference Between the Two Exams — 22; 21; 27; 19 Contrast-enhanced Images — p=< 0.0001
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
Brain Disease
Primary: Global Diagnostic Preference Between the Two Exams — 14; 7; 1; 171 participant exams — p=0.8516
Meniere's Disease
Primary: Vestibular "Endolymphatic Hydrops (EH)" — 0; 4; 2 participants
Breast Cancer
Primary: Cancer Detection Rate (CDR) Per 1,000 Screenings — 8.3; 18.3 CDR per 1,000 screenings
Central Nervous System Pathology
Primary: Overall Diagnostic Preference — 10; 34; 56; 26 Percentage of participants — p=<0.0001
Magnetic Resonance Imaging
Primary: Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) — 1; 0; 2; 3 Participants
Brain Tumor, Primary · Brain Tumor, Recurrent
Primary: Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion — 58; 63 Participants
Central Nervous System Lymphoma · Malignant Glioma · Metastatic Malignant Neoplasm in the Brain
Primary: Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast…
Childhood Brain Neoplasm · Recurrent Childhood Brain Neoplasm
Primary: Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol — .93 mL/g
Coronary Artery Disease
Primary: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1 — 949; 842; 841 Segments Visualized Accurately — p=0.0099
Contrast Media
Primary: Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and…