SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Brain Metastases

Treatments: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Drug: ProHance

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522951

310864 (Other Identifier)

91569

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese patients at least 20 years of age
• Patients with diagnosed primary cancer
• Patients with metastatic lesions by CT/MRI

Exclusion criteria

• Patients who have contraindication to the MRI examinations
• Patients who have severe renal disorder
• Patients in extremely serious general condition

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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165 participants in 3 patient groups

Gadobutrol 0.1 mmol/kg bw

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Gadobutrol 0.2 mmol/kg bw

Experimental group

Description:

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

Treatment:

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Gadoteridol (ProHance)

Experimental group

Description:

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

Treatment:

Drug: ProHance