Magnetic Resonance Imaging
Conditions
Brief summary
This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world. The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.
Detailed description
In order to minimize bias in assessment of the images, blinded reading of the MR images will be performed by 2 blinded readers. The blinded readers will be independent board-certified pediatric radiologists who have no knowledge about the subjects and are not affiliated with any of the clinical sites.
Interventions
DRUGGadoxetate disodium (Eovist/Primovist, BAY86-4873)
Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole \[mmol\]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent \[%\] solution) manually.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No
Inclusion criteria
* Age 0-2 months (must be gestational age 37 to 41 weeks) * Scheduled to undergo routine contrast-enhanced liver MRI * Able to comly with the study procedures
Exclusion criteria
* Scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period * If receiving chemotherapy, may have a change in treatment during the study period * Contraindication for MRI * Renal insufficiency (estimated glomerular filtration rate \< 80% of age-adjusted normal mean value using the Schwartz formula) * Acute renal failure * Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (Note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images | Images were taken pre-injection and post-injection (within about 15 minutes) | Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed. |
| Number of Subjects With Adverse Events | From the signing of the informed consent form until the 6 month post MRI follow-up | An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study. |
| Number of Subjects With Serious Adverse Events | From the signing of the informed consent form until the 6 month post MRI follow-up | An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question | Images were taken pre-injection and post-injection (within about 15 minutes) | Biliary system included 1. Gall bladder 2. Cystic duct 3. Common bile duct 4. Right main bile duct 5. Left main bile duct |
| Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question | Images were taken pre-injection and post-injection (within about 15 minutes) | — |
| Number of Lesions Detected for the Pre-contrast Images | Images were taken pre-injection | — |
| Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Images were taken pre-injection and post-injection (within about 15 minutes) | Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes). |
| Change in Diagnosis for the Combined Images Compared With Precontrast Images | Images were taken pre-injection and post-injection (within about 15 minutes) | Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded. |
| Number of Lesions Detected for the Combined Images | Images were taken pre-injection and post-injection (within about 15 minutes) | — |
| Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question | Images were taken pre-injection and post-injection (within about 15 minutes) | — |
Countries
United States
Participant flow
Recruitment details
Study was conducted at 9 centres in United States of America (USA) and only one participant was recruited in one centre, between 13 February 2015 (first subject first visit) and 11 August 2015 (Last subject last visit).
Pre-assignment details
One participant was enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole \[mmol\]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent \[%\] solution) manually. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images
Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images | 0 participants |
Primary
Number of Subjects With Adverse Events
An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.
Time frame: From the signing of the informed consent form until the 6 month post MRI follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Number of Subjects With Adverse Events | 0 participants |
Primary
Number of Subjects With Serious Adverse Events
An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From the signing of the informed consent form until the 6 month post MRI follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Number of Subjects With Serious Adverse Events | 0 participants |
Secondary
Change in Diagnosis for the Combined Images Compared With Precontrast Images
Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Change in Diagnosis for the Combined Images Compared With Precontrast Images | 0 participants |
Secondary
Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question
Biliary system included 1. Gall bladder 2. Cystic duct 3. Common bile duct 4. Right main bile duct 5. Left main bile duct
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question | Yes | 1 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question | No | 0 number of responses |
Secondary
Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question | Yes | 1 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question | No | 0 number of responses |
Secondary
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question
Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Pre-contrast Images: Very Confident-Yes | 0 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Pre-contrast Images: Confident-Yes | 0 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Pre-contrast Images: Not Confident-No | 1 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Combined Images: Very Confident-Yes | 1 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Combined Images: Confident-Yes | 0 number of responses |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question | Combined Images: Not Confident-No | 0 number of responses |
Secondary
Number of Lesions Detected for the Combined Images
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Number of Lesions Detected for the Combined Images | 0 number of lesions |
Secondary
Number of Lesions Detected for the Pre-contrast Images
Time frame: Images were taken pre-injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Number of Lesions Detected for the Pre-contrast Images | 0 number of lesions |
Secondary
Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question | Pre-contrast Images: Yes | 0 participants |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question | Pre-contrast Images: No | 1 participants |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question | Combined Images: Yes | 0 participants |
| Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) | Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question | Combined Images: No | 1 participants |