Trial Outcomes & Findings for Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions. (NCT NCT01043523)
NCT ID: NCT01043523
Last Updated: 2016-11-28
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
52 participants
Primary outcome timeframe
When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Results posted on
2016-11-28
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
Participants With Unenhanced Images
|
51
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.
Baseline characteristics by cohort
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=52 Participants
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
|
|---|---|
|
Age, Customized
>2 months to ≤2 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
>2 years to ≤12 years
|
25 Participants
n=5 Participants
|
|
Age, Customized
>12 years to <18 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Indication for magnetic resonance imaging (MRI)
Suspected or known focal liver lesions
|
49 Participants
n=5 Participants
|
|
Indication for magnetic resonance imaging (MRI)
Cystic fibrosis
|
1 Participants
n=5 Participants
|
|
Indication for magnetic resonance imaging (MRI)
Biliary atresia
|
1 Participants
n=5 Participants
|
|
Indication for magnetic resonance imaging (MRI)
No clinical indication
|
1 Participants
n=5 Participants
|
|
Physical examination performed at preinjection timepoint
Yes
|
36 Participants
n=5 Participants
|
|
Physical examination performed at preinjection timepoint
No
|
16 Participants
n=5 Participants
|
|
Physical examination performed at postinjection timepoint
Yes
|
35 Participants
n=5 Participants
|
|
Physical examination performed at postinjection timepoint
No
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
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
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
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
Interval 73.7 to 94.3
|
—
|
PRIMARY outcome
Timeframe: 14 days prior to Eovist/Primovist MRIPopulation: The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=40 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point
Increased AST, BUN
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point
Increased AST, AKP
|
1 Participants
|
—
|
|
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 outcome
Timeframe: Up to 24 hours post-Eovist/Primovist MRIPopulation: The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=30 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRIPopulation: The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=30 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Vital Signs: Mean Change From Baseline in Heart Rate
|
-4.17 beats/min
Standard Deviation 16.86
|
—
|
PRIMARY outcome
Timeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRIPopulation: The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=25 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Vital Signs: Mean Change From Baseline in Systolic Blood Pressure
|
-1.76 mmHg
Standard Deviation 17.10
|
—
|
PRIMARY outcome
Timeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRIPopulation: The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=24 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure
|
-0.46 mmHg
Standard Deviation 17.00
|
—
|
SECONDARY outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Relevant change in diagnosis
|
25 Participants
|
—
|
|
Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
No change in diagnosis
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
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
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
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
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: 45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=45 Participants
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
|
Combined Precontrast / Postcontrast
n=45 Participants
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
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
|
1 Participants
|
|
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
|
26 Participants
|
|
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
|
13 Participants
|
|
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
|
2 Participants
|
|
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
|
3 Participants
|
SECONDARY outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
The Overall Image Quality for the Postcontrast Image Only
Satisfactory
|
34 Participants
|
—
|
|
The Overall Image Quality for the Postcontrast Image Only
Excellent
|
8 Participants
|
—
|
|
The Overall Image Quality for the Postcontrast Image Only
Poor
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Final Diagnosis (SoT) by Clinical Investigator
Benign Lesions
|
27 Participants
|
—
|
|
Final Diagnosis (SoT) by Clinical Investigator
Malignant Lesions
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
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.
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
n=51 Participants
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.
Sensitivity [%]
|
66.7 Percentage points
|
70.8 Percentage points
|
|
Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.
Specificity [%]
|
88.9 Percentage points
|
66.7 Percentage points
|
|
Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.
Accuracy [%]
|
78.4 Percentage points
|
68.6 Percentage points
|
OTHER_PRE_SPECIFIED outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Less
|
3 Participants
|
—
|
|
Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Equal
|
34 Participants
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Yes
|
36 Participants
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Yes
|
40 Participants
|
—
|
|
Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
No
|
11 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Larger
|
12 Participants
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRIPopulation: Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)
Outcome measures
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=51 Participants
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
|
Combined Precontrast / Postcontrast
Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
|
|---|---|---|
|
Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Improved
|
39 Participants
|
—
|
|
Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Unchanged
|
12 Participants
|
—
|
|
Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images
Worsened
|
0 Participants
|
—
|
Adverse Events
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Serious events: 21 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=52 participants at risk
Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.5%
7/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Gastrointestinal disorders
Caecitis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
General disorders
Gait disturbance
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
General disorders
Pyrexia
|
5.8%
3/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
General disorders
Device occlusion
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Appendicitis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Bacteraemia
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Bronchitis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Enterococcal bacteraemia
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Herpes zoster
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Lobar pneumonia
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Sepsis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Septic shock
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Tracheitis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Staphylococcal infection
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Rhinovirus infection
|
3.8%
2/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Nervous system disorders
Intracranial aneurysm
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Surgical and medical procedures
Portal shunt
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
Other adverse events
| Measure |
Gadoxetic Acid Disodium (Eovist, BAY86-4873)
n=52 participants at risk
Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
|
|---|---|
|
Surgical and medical procedures
Benign tumour excision
|
1.9%
1/52 • Adverse event data were collected up to 24 hours after Eovist/Primovist injection. Serious adverse event data were collected up to 1 year post the Eovist/Primovist MRI administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place