Adenoma, Carcinoma, Liver Abscess, Liver Neoplasms
Conditions
Keywords
Liver neoplasms, Adenoma, Liver cell carcinoma, Hepatocellular, Liver abscess
Brief summary
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.
Interventions
DRUGGadoxetic Acid Disodium (Eovist, BAY86-4873)
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure | 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 | 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. |
| Vital Signs: Mean Change From Baseline in Systolic Blood Pressure | 14 days prior to and up to 24 hours post-Eovist/Primovist MRI | — |
| Vital Signs: Mean Change From Baseline in Heart Rate | 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 24 Hours Post-injection | 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. |
| Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease. |
| 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 | — |
| 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 | — |
| 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 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 number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images |
| 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 number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images |
Other
| Measure | Time frame |
|---|---|
| Change in Number of 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 Information About Lesion Characterization 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 Size of the Primary Lesion 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 |
| Increased Contrast of Primary Lesion vs Background 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 |
| Improved Border Delineation of the Primary Lesion 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 |
Countries
Italy, Japan, Singapore, Taiwan, United States
Participant flow
Recruitment details
Pediatric subjects (\> 2 months and \< 18 years of age), who underwent a contrast-enhanced (CE) liver magnetic resonance imaging (MRI) with Eovist/Primovist because of suspected or known focal liver lesions, and who had evaluable safety and efficacy data.
Pre-assignment details
Of the 52 subjects that were identified by the investigators for participation in this observational/retrospective study, 51 were included in the efficacy analysis. One subject (22001-0005) did not have unenhanced images. The safety analysis was performed on all 52 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Gadoxetic Acid Disodium (Eovist, BAY86-4873) |
|---|---|
| Age, Customized >12 years to <18 years | 13 Participants |
| Age, Customized >2 months to ≤2 years | 14 Participants |
| Age, Customized >2 years to ≤12 years | 25 Participants |
| Indication for magnetic resonance imaging (MRI) Biliary atresia | 1 Participants |
| Indication for magnetic resonance imaging (MRI) Cystic fibrosis | 1 Participants |
| Indication for magnetic resonance imaging (MRI) No clinical indication | 1 Participants |
| Indication for magnetic resonance imaging (MRI) Suspected or known focal liver lesions | 49 Participants |
| Physical examination performed at postinjection timepoint No | 17 Participants |
| Physical examination performed at postinjection timepoint Yes | 35 Participants |
| Physical examination performed at preinjection timepoint No | 16 Participants |
| Physical examination performed at preinjection timepoint Yes | 36 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 52 |
| serious Total, serious adverse events | 21 / 52 |
Outcome results
Primary
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection
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.
Time frame: Up to 24 hours post-Eovist/Primovist MRI
Population: The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection | 0 Participants |
Primary
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point
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.
Time frame: 14 days prior to Eovist/Primovist MRI
Population: The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point | Increased AST, BUN | 1 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point | Increased AST, AKP | 1 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point | High liver values due to gastrointestinal (GI) | 1 Participants |
Primary
Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.
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
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images. | 86.3 Percentage of participants |
Primary
Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure
Time frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Population: The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure | -0.46 mmHg | Standard Deviation 17 |
Primary
Vital Signs: Mean Change From Baseline in Heart Rate
Time frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Population: The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Vital Signs: Mean Change From Baseline in Heart Rate | -4.17 beats/min | Standard Deviation 16.86 |
Primary
Vital Signs: Mean Change From Baseline in Systolic Blood Pressure
Time frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Population: The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Vital Signs: Mean Change From Baseline in Systolic Blood Pressure | -1.76 mmHg | Standard Deviation 17.1 |
Secondary
Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Blinded reader was confident in the diagnosis | 10 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Blinded reader was not confident in the diagnosis | 41 Participants |
Secondary
Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Relevant change in diagnosis | 25 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No change in diagnosis | 26 Participants |
Secondary
Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Change in the number of malignant lesions | 11 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No change in the number of malignant lesions | 40 Participants |
Secondary
Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Change in the number of non-malignant lesions | 18 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No change in the number of non-malignant lesions | 33 Participants |
Secondary
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)
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: 45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | 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) | Biopsy | 0 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | 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) | Other | 37 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | 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) | Follow-up examination | 1 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | 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) | No action | 0 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | 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) | Ultrasound | 7 Participants |
| Combined Precontrast / Postcontrast | 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) | No action | 3 Participants |
| Combined Precontrast / Postcontrast | 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) | Ultrasound | 1 Participants |
| Combined Precontrast / Postcontrast | 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) | Biopsy | 26 Participants |
| Combined Precontrast / Postcontrast | 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) | Follow-up examination | 13 Participants |
| Combined Precontrast / Postcontrast | 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) | Other | 2 Participants |
Secondary
Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Change from subject management therapy | 45 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No change in subject management therapy | 6 Participants |
Secondary
Final Diagnosis (SoT) by Clinical Investigator
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Final Diagnosis (SoT) by Clinical Investigator | Benign Lesions | 27 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Final Diagnosis (SoT) by Clinical Investigator | Malignant Lesions | 24 Participants |
Secondary
Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.
Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Sensitivity [%] | 66.7 Percentage points |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Specificity [%] | 88.9 Percentage points |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Accuracy [%] | 78.4 Percentage points |
| Combined Precontrast / Postcontrast | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Sensitivity [%] | 70.8 Percentage points |
| Combined Precontrast / Postcontrast | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Specificity [%] | 66.7 Percentage points |
| Combined Precontrast / Postcontrast | Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. | Accuracy [%] | 68.6 Percentage points |
Secondary
The Overall Image Quality for the Postcontrast Image Only
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | The Overall Image Quality for the Postcontrast Image Only | Satisfactory | 34 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | The Overall Image Quality for the Postcontrast Image Only | Excellent | 8 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | The Overall Image Quality for the Postcontrast Image Only | Poor | 9 Participants |
Other Pre-specified
Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Improved | 39 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Unchanged | 12 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Worsened | 0 Participants |
Other Pre-specified
Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Less | 3 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Equal | 34 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | More | 14 Participants |
Other Pre-specified
Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Larger | 12 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No change | 38 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Smaller | 1 Participants |
Other Pre-specified
Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Yes | 36 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No | 15 Participants |
Other Pre-specified
Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Time frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Population: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | Yes | 40 Participants |
| Gadoxetic Acid Disodium (Eovist, BAY86-4873) | Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images | No | 11 Participants |