Trial Outcomes & Findings for 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 (NCT NCT02084628)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

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

Results posted on

2016-09-23

Participant Flow

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).

One participant was enrolled in the study.

Participant milestones

Participant milestones
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) Participant 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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Number of Subjects With Adverse Events	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Number of Subjects With Serious Adverse Events	0 participants

SECONDARY outcome

Timeframe: Images were taken pre-injection

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Number of Lesions Detected for the Pre-contrast Images	0 number of lesions

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Number of Lesions Detected for the Combined Images	0 number of lesions

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question Yes	1 number of responses
Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question No	0 number of responses

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question Yes	1 number of responses
Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question No	0 number of responses

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question Pre-contrast Images: Yes	0 participants
Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question Pre-contrast Images: No	1 participants
Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question Combined Images: Yes	0 participants
Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question Combined Images: No	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
Change in Diagnosis for the Combined Images Compared With Precontrast Images	0 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Gadoxetate Disodium (Eovist/Primovist, BAY86-4873) n=1 Participants 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.
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
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question Pre-contrast Images: Confident-Yes	0 number of responses
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
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question Combined Images: Very Confident-Yes	1 number of responses
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question Combined Images: Confident-Yes	0 number of responses
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question Combined Images: Not Confident-No	0 number of responses

Adverse Events

Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head

Bayer AG

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place