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Gadoxetic Acid Disodium

Phase 3

Known or Suspected Focal Liver Lesions | Small molecule | Gastrointestinal |Bayer AG|Last Updated: May 1, 2015

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment234

FDA Designations

No designations recorded

Clinical trial landscape

Gadoxetic Acid Disodium · 1 trial · 1 indication

Phase 3 1
NCT00526188Efficacy and Safety of Primovist in Chinese PatientsKnown or Suspected Focal Liver Lesions
COMPLETED234 Analytics
PHASE3COMPLETED
Efficacy and Safety of Primovist in Chinese Patients
Known or Suspected Focal Liver Lesions
NCT00526188234
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Study Endpoints

Primary Endpoints

Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points
Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).

Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)\*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.

Secondary Endpoints

Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points
Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).
Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points
Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Gadoxetic Acid Disodium (Primovist, BAY86-4873)EXPERIMENTALBolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient

Interventions

NameTypeDescription
Gadoxetic Acid Disodium (Primovist, BAY86-4873)DRUGBolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Patients between 18 and 75 years of age inclusive. * Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP...

Countries:China
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Frequently asked questions about Gadoxetic Acid Disodium

What is Gadoxetic Acid Disodium used for?

Gadoxetic Acid Disodium is used for the detection and characterization of known or suspected focal liver lesions. It is a contrast agent being developed by Bayer AG for use in magnetic resonance imaging of the liver. The drug is currently in Phase 3 clinical development and is not yet approved.

What does Gadoxetic Acid Disodium target?

Gadoxetic Acid Disodium is a gadolinium-based contrast agent that works by accumulating in liver tissue and enhancing the visibility of focal liver lesions during magnetic resonance imaging. It is taken up by hepatocytes and provides both dynamic and hepatobiliary phase imaging, allowing for improved detection and characterization of liver lesions.

Who makes Gadoxetic Acid Disodium?

Gadoxetic Acid Disodium is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is being investigated for use in patients with known or suspected focal liver lesions.

What phase is Gadoxetic Acid Disodium in?

Gadoxetic Acid Disodium is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its efficacy and safety in patients with known or suspected focal liver lesions.

What clinical trials is Gadoxetic Acid Disodium in?

Gadoxetic Acid Disodium has one completed Phase 3 clinical trial, identified as NCT00526188, titled 'Efficacy and Safety of Primovist in Chinese Patients'. This trial enrolled 234 participants in China and evaluated the drug in patients with known or suspected focal liver lesions. The trial was uncontrolled and not randomized.

Is Gadoxetic Acid Disodium the same as Primovist?

Yes, Gadoxetic Acid Disodium is also known as Primovist. The Phase 3 clinical trial NCT00526188, which evaluated the drug in Chinese patients with focal liver lesions, used the name Primovist in its title. This alternative name is commonly used in clinical and commercial settings.