Conditions: Brain Metastases
Keywords: MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 165
Healthy volunteers: no

Brief summary:
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.

Detailed description:

Arms:
arm 1: Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw arm 2: Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min arm 3: Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min

Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 3: ProHance
Intervention descriptions: intervention 1: Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw) intervention 2: Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) intervention 3: ProHance enhanced MRI (two injections of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw)

Protocol document: