An Observational Study of the Administration of Eovist/Primovist in Pediatric Subjects (> 2 Months and Less Than 18 Years) Who Are Referred for a Routine Contrast Enhanced Liver MRI Because of Suspected or Known Focal Liver Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 52
- 主要终点
- Vital Signs: Mean Change From Baseline in Systolic Blood Pressure
研究概览
简要总结
Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >2 months and <18 years of age at the time of the Primovist/Eovist enhanced MRI
- •MRI with Primovist/Eovist due to suspected or known focal liver lesions
- •Evaluable safety data
- •Evaluable efficacy data: precontrast and postcontrast magnetic resonance (MR) images must be available for review
- •If the above criteria are met, the principal investigator (PI) and/or designee will obtain a signed consent for medical records release including access to anonymized electronic copies of the pre- and post-Primovist/Eovist MRI scans, in accordance with local regulatory requirements in order for subjects to be enrolled in the study.
排除标准
- •A subject will be excluded from this observational / retrospective study if the subject has previously been enrolled into this study. Subjects may only be entered once into this study, even if they have been imaged multiple times and for different indications.
研究组 & 干预措施
Group 1
干预措施: Gadoxetic Acid Disodium (Eovist, BAY86-4873) (Drug)
结局指标
主要结局
Vital Signs: Mean Change From Baseline in Systolic Blood Pressure
时间窗: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.
时间窗: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened
Vital Signs: Mean Change From Baseline in Heart Rate
时间窗: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure
时间窗: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point
时间窗: 14 days prior to Eovist/Primovist MRI
Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection
时间窗: Up to 24 hours post-Eovist/Primovist MRI
The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.
次要结局
- Change in Recommended Next Course of Subject Management / Therapy - Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented)(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Final Diagnosis (SoT) by Clinical Investigator(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- The Overall Image Quality for the Postcontrast Image Only(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)
- Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.(When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI)