Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OptiMARK~0.1 mmol/kg BW · 1 trial · 2 indications
The primary visualization variables (number \[no.\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.
Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.
The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.
The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.
The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.
CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.
| Arm | Type | Description |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | EXPERIMENTAL | Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | EXPERIMENTAL | Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | EXPERIMENTAL | Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
| Name | Type | Description |
|---|---|---|
| Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) | DRUG | Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
| Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) | DRUG | Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
| Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) | DRUG | Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
| OptiMARK~0.1 mmol/kg BW | DRUG | Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
Inclusion Criteria: * Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-e...
OptiMARK~0.1 mmol/kg BW is a small molecule being developed for use in brain diseases, specifically for imaging in central nervous system conditions. It is an investigational agent studied in the context of magnetic resonance imaging (MRI) for brain and spinal cord diseases. The drug is in Phase 2 clinical development.
OptiMARK~0.1 mmol/kg BW is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical research on this investigational agent for use in brain and spinal cord imaging.
OptiMARK~0.1 mmol/kg BW is in Phase 2 clinical development. It is an investigational agent, meaning it has not been approved by regulatory authorities. The drug is being studied for use in brain diseases, particularly for magnetic resonance imaging of the central nervous system.
OptiMARK~0.1 mmol/kg BW was studied in a completed Phase 2 clinical trial with the identifier NCT00862459. This trial was a dose-finding study of Gadavist in central nervous system (CNS) magnetic resonance imaging (MRI). The study enrolled 237 participants and was conducted in the United States, Argentina, Brazil, and Colombia.
OptiMARK~0.1 mmol/kg BW is associated with the clinical trial NCT00862459, which is titled "Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)." The trial investigates Gadavist, and OptiMARK~0.1 mmol/kg BW appears to be a formulation or dosage of this agent.