Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent

• ClinicalTrials.gov Identifier: NCT02084628
• Recruitment Status: Terminated
• First Posted: March 12, 2014
• Results First Posted: September 23, 2016
• Last Update Posted: September 23, 2016
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: February 6, 2014
• First Posted Date: March 12, 2014
• Results First Submitted Date: August 4, 2016
• Results First Posted Date: September 23, 2016
• Last Update Posted Date: September 23, 2016
• Study Start Date: February 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2016)

• Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: March 10, 2014)

• Number of participants with additional diagnostic information from combined (pre-contrast and post-contrast) compared with pre-contrast images [ Time Frame: Up to 1 year after injection ]
  Number of participants with better: delineation of the border of the lesion, definition of the internal morphology of the lesion, characterization of the lesion, definition of the location of the lesion, assessment of the communication of the lesion with respect to the biliary system and other, specify
• Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 24 hours after injection ]
• Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 6 months after injection ]

Current Secondary Outcome Measures (submitted: August 4, 2016)

• Number of Lesions Detected for the Pre-contrast Images [ Time Frame: Images were taken pre-injection ]
• Number of Lesions Detected for the Combined Images [ Time Frame: 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 [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
• Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question [ Time Frame: 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 [ Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes) ]
• Change in Diagnosis for the Combined Images Compared With Precontrast Images [ Time Frame: 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.
• Diagnostic Confidence 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) ]
  Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).

Original Secondary Outcome Measures (submitted: March 10, 2014)

• Number of lesions detected for the pre-contrast images [ Time Frame: Up to 1 year after injection ]
• Number of lesions detected for the combined images [ Time Frame: Up to 1 year after injection ]
• Number of participants with contrast enhancement of the biliary system for the combined images [ Time Frame: Up to 1 year after injection ]
  If relevant to the subject
• Contrast enhancement of the biliary system for the combined images assessed by yes or no question [ Time Frame: Up to 1 year after injection ]
  This is only assessed if it is relevant to the subject
• Number of participants with visualization of the biliary system for the pre-contrast images [ Time Frame: Up to 1 year after injection ]
  If relevant to the subject
• Number of participants with visualization of the biliary system for the combined images [ Time Frame: Up to 1 year after injection ]
  If relevant to the subject
• Number of participants with diagnostic confidence for the pre-contrast images [ Time Frame: Up to 1 year after injection ]
• Number of participants with diagnostic confidence for the combined images [ Time Frame: Up to 1 year after injection ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent
• Official Title: Open-label, Multi-center Study to Evaluate the Safety, Efficacy, and Plasma Gadolinium Concentrations After an Intravenous Injection of 0.1 mL/kg Body Weight Eovist/Primovist for Enhanced Magnetic Resonance Imaging (MRI) of the Liver in Children 0 to 2 Months of Age

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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Magnetic Resonance Imaging

Intervention

Drug: 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.

Study Arms

Experimental: 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.

Intervention: Drug: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 20, 2015): 1
• Original Estimated Enrollment (submitted: March 10, 2014): 10
• Actual Study Completion Date: August 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 2 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02084628
• Other Study ID Numbers: 16078; 2012-000952-32 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bayer
• Original Responsible Party: Same as current
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: August 2016