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Gadoxetic Acid Disodium · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Gadoxetic Acid Disodium (Primovist, BAY86-4873) | EXPERIMENTAL | Bolus 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 |
| Name | Type | Description |
|---|---|---|
| Gadoxetic Acid Disodium (Primovist, BAY86-4873) | DRUG | Bolus 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 |
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...
Gadoxetic Acid Disodium is a small molecule contrast agent developed by Bayer AG for magnetic resonance imaging of the liver. It is used in patients with known or suspected focal liver lesions, helping clinicians visualize and characterize lesions during MRI examinations. It is also known by the brand name Primovist and the development code BAY86-4873.
Gadoxetic Acid Disodium is used for imaging in patients with known or suspected focal liver lesions. It is a contrast agent administered during magnetic resonance imaging of the liver to help detect and characterize focal lesions. Its development has focused on this gastrointestinal imaging indication.
Gadoxetic Acid Disodium is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical development program for this liver imaging contrast agent, including the Phase 3 study conducted in Chinese patients.
Gadoxetic Acid Disodium is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study enrolled 234 patients with known or suspected focal liver lesions in China.
Gadoxetic Acid Disodium has been studied in the Phase 3 trial NCT00526188, titled Efficacy and Safety of Primovist in Chinese Patients. The trial enrolled 234 participants aged 18 years and older with known or suspected focal liver lesions, was conducted in China, and has completed.
Yes, Gadoxetic Acid Disodium is also known as Primovist and by the development code BAY86-4873. Primovist is the brand name used for this Bayer liver imaging agent, so searches for Primovist refer to the same product as Gadoxetic Acid Disodium.