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

NCT02084628 | Terminated Phase 3 Results

• 2 other identifiers: 160782012-000952-32
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 9

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.

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• 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.

  Images were taken pre-injection and post-injection (within about 15 minutes)

• 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.

  From the signing of the informed consent form until the 6 month post MRI follow-up

• 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.

  From the signing of the informed consent form until the 6 month post MRI follow-up

Secondary Outcomes (7)

• Number of Lesions Detected for the Pre-contrast Images

  Images were taken pre-injection

• 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)

• 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)

• 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)

Study Arms (1)

Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

EXPERIMENTAL

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.

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

Interventions

Gadoxetate disodium (Eovist/Primovist, BAY86-4873) DRUG

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.

Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bayer: lead

Study Sites (9)

Unknown Facility

Los Angeles, California, 90027-6089, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Brooklyn, New York, 11219, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Cincinnati, Ohio, 45229, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

Unknown Facility

Madison, Wisconsin, 53792, United States

Location

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Interventions

gadolinium ethoxybenzyl DTPA

Limitations and Caveats

Primarily based on study 13729 along with supporting data the FDA revised Eovist labeling to remove any age restriction from indication and decided that there are no further pediatric data requested. Consequently, study was discontinued.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: March 12, 2014
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 23, 2016
• Results First Posted: September 23, 2016

Record last verified: 2016-08

Locations

US (9)